Compounding: Inspections, Recalls, and other Actions

Find 2014 - 2015 Compounding: Inspections, Recalls, and other Actions in the FDA Archive

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Abbott's Compounding Pharmacy Inc., Berkeley, CA

Warning Letter (04/04/2017)
483 Issued 01/08/2016 (PDF - 2MB)

ABC Pharmacy, Inc., Encino, CA

FMD-145 Letter Issued 07/06/2020 (PDF - 63KB)
Referral Letter to the California State Board of Pharmacy Issued 07/06/2020 (PDF - 80KB)
483 Issued 12/20/2019 (PDF - 254KB)

Abilene Nuclear LLC, (dba National Central Pharmacy), Abilene, TX

Untitled Letter Issued 10/22/2020 (PDF - 818KB)
483 Issued 11/07/2019 (PDF - 928KB)

Abrams Royal Pharmacy, Dallas, TX

Warning Letter (07/14/2014)
FDA Press Release: FDA Announces Voluntary Nationwide Recall of All Non-expired Sterile Drugs from Abrams Royal Compounding Pharmacy (12/21/2013)
483 Issued 12/20/2013 (PDF – 5.3MB)
Firm Press Release: Abrams Royal Pharmacy Issues Voluntary Nationwide Recall of All Lots of Unexpired Sterile Products Due to Lack of Sterility Assurance (12/18/2013)

Abrams Royal Pharmacy II, LLC, Plano, TX

FMD-145 Letter Issued 05/03/2016 (PDF - 275KB)
483 Issued 5/11/2015 (PDF - 466KB)

Absolute Pharmacy, LLC, Lutz, FL

Referral Letter to the Florida State Board of Pharmacy Issued 02/15/2017 (PDF - 307KB)
483 Issued 04/11/2016 (PDF - 1.7MB)
Warning Letter (04/27/2015)
483 Issued 11/19/2014

Absolute Veterinary Compounding Pharmacy, Weatherford, TX

FMD-145 Letter Issued 02/01/2021 (PDF - 177KB)
483 Issued 06/14/2017 (PDF - 125KB)

AcariaHealth Pharmacy, Inc., Falls Chuch, VA

Referral Letter to the Virginia State Board of Pharmacy dated 01/29/2020 (PDF - 113KB)
FMD-145 Letter Issued 01/29/2020 (PDF - 121KB)
483 Issued 09/12/2018 (PDF - 534KB)

Accurate Rx Pharmacy Consulting, LLC (dba Accurate Rx Pharmacy), Columbia, MO

483 Issued 07/15/2021 (PDF - 1.01MB)
Warning Letter (09/02/2020)
483 Issued 09/19/2018 (PDF - 630KB)
483 Issued 08/15/2017 (PDF - 228KB)

A Chem Rx, LLC, (dba Cortez Drugs), Brooksville, FL

FMD-145 Letter Issued 06/16/2020 (PDF - 184KB)
483 Issued 02/07/2020 (PDF - 266KB)

ACRX Specialty Pharmacy Inc., Las Vegas, NV

483 Issued 07/23/2021 (PDF - 1.33MB)
Warning Letter (07/24/2020)
483 Issued 03/20/2019 (PDF - 1.64MB)

Advanced Care Infusion-Shelby, (see Tri-Med, Inc.), Shelby Township, MI

Advanced Compounding Solutions, (see New England Life Care, Inc.), Woburn, MA

Advanced Infusion Solutions, Clinton, MS

483 Response Dated 11/16/2015 (PDF - 1.3MB)
483 Issued 10/27/2015 (PDF - 621KB)

Advanced Infusion Solutions, (see Bond Pharmacy, Inc.), Ridgeland, MS

Advanced Nutriceuticals, LLC, Indianapolis, IN

Warning Letter (11/10/2021)
483 Issued 10/29/2020 (PDF - 3.61MB)

Advanced Physician Solutions, Inc., N Hollywood, CA

Warning Letter (11/03/2015)
483 Issued 01/16/2015 (PDF - 2.4MB)

Advanced Specialty Pharmacy (dba Meds IV), Bessemer, AL

DOJ Press Release: Federal Criminal Charges Filed Against Two Pharmacists for Adulteration of Drugs in Connection with Alabama-Based Compounding Pharmacy (1/28/2016)
Warning Letter (03/16/2012)

Aerosol Science Laboratories Inc., Camarillo, CA

Warning Letter (10/29/2008)

Age Management, Santa Barbara, CA

Warning Letter (04/18/2022)
483 Issued 04/12/2021 (PDF - 1.25MB)

Akina Pharmacy, Chantilly, VA

Referral Letter to the Virginia State Board of Pharmacy Issued 06/08/2017 (PDF - 62KB)
483 Issued 08/10/2016 (PDF - 492KB)

Akorn Pharmaceuticals Inc. Decatur, IL

483 Issued 06/10/2016 (PDF - 1.7MB)

Alexander Infusion, LLC (dba Avanti Health Care Services), New Hyde Park, NY

Warning Letter Closeout (05/08/2017)
Referral Letter to the New York State Board of Pharmacy Issued 05/08/2017 (PDF - 646KB)
FMD-145 Letter Issued 05/08/2017 (PDF - 267KB)
483 Issued 08/01/2016 (PDF - 607KB)
Warning Letter (03/27/2015)
483 Issued 07/09/2014 (PDF - 1.4MB)

Alexandria Medical Arts Pharmacy & Compounding Laboratory, (see J & F International Inc.), Alexandria, VA

Alfred I. duPont Hospital for Children, Wilmington, DE

Referral Letter to the Delaware State Board of Pharmacy Issued 04/28/2017 (PDF - 910KB)
483 Issued 06/29/2016 (PDF - 686KB)

Algunas, Inc. (dba Woodland Hills Compounding Pharmacy), Woodland Hills, CA

483 Issued 10/11/2018 (PDF - 1.14MB)
Amended 483 Issued 05/02/2016 (PDF - 374KB)
483 Issued 04/29/2016 (PDF - 427KB)
Warning Letter 7/17/2017

Allegheny Health Network Home Infusion, LLC, Sharpsburg, PA

483 Issued 09/25/2018 (PDF - 224KB)

Alwan's Pharmacy (see American Pharmacy of Illinois, Inc.), Peoria, IL

Ambient Healthcare of Central Florida Inc., Ocala, FL

Referral Letter to Florida State Board of Pharmacy Issued 10/09/2015 (PDF - 321KB)
483 Issued 09/15/2014 (PDF - 637KB)

American Family Pharmacy, LLC, Indianapolis, IN

Amended 483 Issued 07/21/2014 (PDF - 1.8MB)
483 Issued 07/08/2014 (PDF - 2.3MB)

American Hormones Inc. Poughkeepsie, NY

FMD-145 Letter Issued 04/06/2016 (PDF - 81KB)

American Hormones, Inc., Wappingers Falls, NY

Warning Letter (01/10/2008)

American Pharmacy of Illinois, Inc. (dba Alwan's Pharmacy), Peoria, IL

483 Issued 07/17/2018 (PDF - 988KB)
Warning Letter (07/22/2016)
Amended 483 Issued 11/17/2015 (PDF - 1.4MB)
483 Issued 10/28/2015 (PDF - 1.4MB)

American Specialty Pharmacy, Dallas, TX

Warning Letter (04/04/2017)
483 Issued 08/05/2015 (PDF - 998KB)

American Specialty Pharmacy, Plano, TX

Warning Letter (06/28/2016)
483 Issued 12/19/2014

American Specialty Pharmacy, Inc., (dba ASP Cares), San Antonio, TX

Warning Letter (04/05/2021)
483 Issued 08/23/2018 (PDF - 1016KB)
FMD-145 Letter Issued 10/26/2017 (PDF - 63KB)
483 Issued 03/02/2017 (PDF - 261KB)

Americare Compounding, LLC, Garden City South, NY

Referral Letter to the New York State Board of Pharmacy Issued 03/22/2017 (PDF - 223KB)
483 Issued 06/22/2015 (PDF - 903KB)
Warning Letter (04/22/2014)
483 Issued 06/19/2013 (PDF – 754KB)

Ameridose, LLC, Westborough, MA

483 Issued 11/09/2012
Firm Press Release: Ameridose Issues Recall of All Products (10/31/2012)
FDA Press Release: FDA reports voluntary recall of all Ameridose drugs products (10/31/2012)

Amex Pharmacy, (see Pacifico National Inc.), Melbourne, FL

Anazaohealth Corporation, Tampa, FL

Referral Letter to Florida Board of Pharmacy Issued 02/21/2014 (PDF - 375KB)
483 Issued 02/22/2013 (PDF - 857KB)

Anazaohealth Corporation, Las Vegas, NV

Warning Letter (08/18/2021)
483 Issued 09/19/2019 (PDF - 501KB)
Amended 483 Issued 04/06/2017 (PDF - 1.3MB)
483 Issued 03/24/2017 (PDF - 1MB)
Warning Letter (12/09/2015)
483 Issued 01/30/2015 (PDF - 2MB)

Anchor Drugs Pharmacy, (see Jajco, Inc.), South San Francisco, CA

Anderson Compounding Pharmacy, Inc. dba Anderson Compounding Pharmacy, Bristol, TN

Warning Letter (01/13/2020)
483 Issued 04/05/2019 (PDF - 1.09MB)

Anderson Holdings Inc. (dba Wingate's Pharmacy and Compounding), Nashua, NH

Referral Letter to State of New Hampshire Board of Pharmacy Issued 06/07/2016 (PDF - 32KB)
483 Response Dated 02/29/2016 (PDF - 1.6MB)
483 Issued 02/19/2016 (PDF - 1.7MB)

Apex Pharmacy, LLC, Beckley, WV

Untitled Letter Issued 07/28/2020 (PDF - 164KB)
483 Issued 11/07/2019 (PDF - 250KB)

Apollo Care LLC, Columbia, MO

483 Issued 09/8/2021 (PDF - 2 MB)
Warning Letter (03/20/2019)
483 Issued 03/13/2018 (PDF - 2.5MB)

ApothéCure, Inc., Dallas, TX

483 Issued 04/17/2013 (PDF - 1.6MB)
Firm Press Release: ApothéCure, Inc. Recalls All Lots of All Sterile Products Compounded, Repackaged, and Distributed by ApothéCure, Inc. Due to Sterility Assurance Concerns (04/15/2013)
FDA Press Release: FDA issues Alert About Lack of Sterility Assurance of Drug Products from ApothéCure, Inc. and NuVision Pharmacy and of Forthcoming Recall (04/15/2013)
DOJ Press Release: Dallas Compounding Pharmacy Owner Pleads Guilty in Connection with Misbranded Drug Shipment (4/24/2012)

APS Pharmacy, (see Drug Depot, Inc.), Palm Harbor, FL

ARJ Infusion Services, Inc., Lenexa, KS.

FMD-145 Letter Issued 03/06/2019 (PDF - 88KB)
Warning Letter CloseOut (03/06/2019)
Referral Letter to the Kansas State Board of Pharmacy Issued 03/06/2019 (PDF - 73KB)
Warning Letter (04/02/2018)
483 Issued 05/25/2017 (PDF - 296KB)

Ark Pharmacy, PC (dba Regency Medical Pharmacy), Newbury Park, CA

483 Issued 2/24/2022 (PDF - 271 KB)

Arnold Professional Pharmacy, Arnold, MD

483 Issued 09/05/2018 (PDF - 183KB)
Warning Letter (04/07/2017)
483 Issued 05/06/2016 (PDF - 385KB)

ASP Cares, (see American Specialty Pharmacy, Inc.), San Antonio, TX

Aspirar Pharmacy, LLC, Cary, NC

Referral Letter to the North Carolina State Board of Pharmacy Issued 08/19/2019 (PDF - 65KB)
FMD-145 Letter Issued 08/19/2019 (PDF - 63KB)

Assurance Infusion, (see Nanobots Healthcare, LLC), Houston, TX

Asteria Health, (see FH Investments Inc.), Birmingham, AL

Athena Pharmacy (see Paradigm Healthcare Solutions, LLC), Mount Juliet, TN

Athenex Pharma Solutions, LLC, Clarence, NY

483 Issued 08/28/2019 (PDF - 334KB)
FDA Statement: FDA Statement on Court Ruling Related to Compounded Bulk Drug Substances and the Agency’s Ongoing Efforts to Implement its Compounding Authorities (08/06/2019)
Firm Press Release: Athenex Provides an Update Regarding the Vasopressin Case (08/02/2019)
Untitled Letter Issued 02/13/2019 (PDF - 161KB)
483 Issued 12/13/2017 (PDF - 598KB)

Atlas Pharmaceuticals, LLC, Phoenix, AZ

483 Issued 06/11/2021 (PDF - 860KB
Warning Letter (09/11/2018)
483 Issued 09/26/2017 (PDF - 2.8MB)

Auro Pharmacies, Inc., La Habra, CA

483 Issued 10/18/2019 (PDF - 1.93MB)
Warning Letter (09/24/2018)
483 Issued 06/29/2017 (PDF - 2.9MB)
Warning Letter (12/13/2016)
Amended 483 Issued 12/02/2016 (PDF - 1.9MB)
483 Issued 12/02/2016 (PDF - 2MB)
483 Issued 11/05/2015 (PDF - 1.7MB)

Avanti Health Care Services, (see Alexander Infusion, LLC), New Hyde Park, NY

Avella of Deer Valley, Inc. (dba Avella Specialty Pharmacy), Phoenix, AZ

Untitled Letter Issued 03/31/2021 (PDF - 171KB)
483 (Amendment 2) Issued 04/25/2018 (PDF - 778KB)
483 Issued 04/20/2018 (PDF - 697KB)
483 (Amendment 1) Issued 04/19/2018 (PDF - 724KB)
FMD-145 Letter Issued 08/23/2017 (PDF - 53KB)
FMD-145 Letter Issued 02/15/2017 (PDF - 187KB)
Untitled Letter Issued 02/03/2017 (PDF - 1.33MB)
Amended 483 Issued 07/31/2015 (PDF - 297KB)
483 Issued 07/29/2015 (PDF - 567KB)
Warning Letter Response Dated 02/10/2014
Warning Letter (01/17/2014)
Firm Press Release: Avella Specialty Pharmacy Issues Voluntary Nationwide Recall of Two Medications Due to Concerns of Sterility Assurance at Testing Vendor (09/09/2013)
483 Issued 02/25/2013 (PDF - 1010KB)

Avella Specialty Pharmacy, (formerly Advanced Pharma, Inc.), Houston, TX

Untitled Letter Issued 08/14/2018 (PDF - 88KB)
Firm Press Release: Advanced Pharma, Inc. d/b/a Avella of Houston Issues Voluntary Nationwide Recall of Specific Lots of Potassium Phosphate and Succinylcholine Repacked and/or Compounded at its Houston Location as a Result of Hospira, Inc’s June 15, 2017 Recall of Such Products Due to a Potential Lack of Sterility Assurance (06/22/2017)
Firm Press Release: Advanced Pharma, Inc. D/B/A Avella of Houston Issues Voluntary Nationwide Recall of All Unexpired Nitroglycerin Injection In 5% Dextrose USP Products Produced At Its Houston Location From March 3, 2017 Through May 31, 2017 Due To Sub-Potency (06/15/2017)
Firm Press Release: Avella Specialty Pharmacy Issues Voluntary Nationwide Recall of all Sterile Products Produced at Advanced Pharma Houston Location from September 1, 2016 through February 16, 2017 Due to Potential Inaccuracy of Latex Free Label Reference (02/23/2017)
483 Issued 07/22/2016 (PDF - 920KB)
483 Issued 03/17/2014 (PDF - 638KB)

Avenue Pharmacy, Inc., (dba Pathway Pharmacy), Ocala, FL

483 Issued 12/06/2019 (PDF - 499KB)

Axia Pharmaceuticals, (see Fusion IV Pharmaceuticals Inc.), Los Angeles, CA

Axis Pharmacy Northwest, (see Shiraz Specialty Pharmacy Inc.), Mountlake Terrace, WA

Axium Healthcare Pharmacy (dba Balanced Solutions Compounding), Lake Mary, FL

Warning Letter (07/16/2013)
FDA Press Release: FDA Announces Voluntary Nationwide Recall by Balanced Solutions Compounding Pharmacy (04/21/2013)
Firm Press Release: Balanced Solutions Compounding Pharmacy, LLC. Announces a Voluntary Nationwide Recall of All Sterile Compounded Products Due to a Lack of Sterility Assurance (04/17/2013)
483 Issued 03/15/2013 (PDF - 638KB)

B & B Pharmacy, (see BBS Pharmacy, Inc.), Bellflower, CA

Balanced Solutions Compounding, (see Axium Healthcare Pharmacy), Lake Mary, FL

Ballard Plaza Pharmacy 1 Inc., Seattle, WA

Warning Letter (08/01/2017)
Amended 483 Issued 06/10/2016 (PDF - 1.7MB)
483 Issued 05/17/2016 (PDF - 1.6MB)

Banner Pharmacy Services, LLC, Chandler, AZ

FMD-145 Letter Issued 04/09/2020 (PDF - 63KB)
Referral Letter to the Arizona State Board of Pharmacy Issued 04/09/2020 (PDF - 83KB)
483 Issued 10/08/2019 (PDF - 1.15MB)
Amended 483 Issued 09/20/2017 (PDF - 3.1MB)
483 Issued 09/20/2017 (PDF - 2.9MB)
Warning Letter (05/05/2016)
483 Issued 03/20/2015 (PDF - 1.8MB)

Baptist Health Medical Towers Pharmacy and Infusion Services, Little Rock, AR

Warning Letter (09/12/2017)
483 Issued 04/28/2016 (PDF - 1.3MB)

Barclay Luke & Pillai Specialty Pharmacy PLLC (dba Meta Pharmacy Services), Las Vegas, NV

483 Issued 12/14/2018 (PDF - 1.5MB)
483 Issued 12/20/2016 (PDF - 3MB)

Baycare Integrated Service Center, LLC dba BayCare Central Pharmacy, Temple Terrace, FL

483 Issued 12/10/2019 (PDF - 951KB)

Bayview Pharmacy, Inc., Saunderstown, RI

Referral to the Rhode Island State Board of Pharmacy Issued 07/25/2017 (PDF - 79KB)
483 Issued 8/18/2016 (PDF - 769KB)

BBS Pharmacy, Inc. (dba B&B Pharmacy), formerly Pacific Healthcare, Inc., Bellflower, CA

FMD-145 Letter Issued 08/31/2017 (PDF - 54KB)
Referral Letter to the California State Board of Pharmacy Issued 08/31/2017 (PDF - 52KB)
Warning Letter (09/02/2016)
483 Response Dated 09/09/2015 (PDF - 2.2MB)
Amended 483 Issued 08/18/2015 (PDF - 1.7MB)
483 Issued 08/18/2015 (PDF - 2.2MB)

Beacon Hill Medical Pharmacy, P.C. (dba Rxtra Solutions), Southfield, MI

Warning Letter (09/24/2014)
Firm Press Release: Beacon Hill Medical Pharmacy, P.C. (dba Rxtra Solutions) Issues Voluntary Nationwide Recall of Certain Sterile Products Due to a Question of Sterility Assurance (07/31/2013)
483 Issued 07/19/2013 (PDF – 2.7MB)

Beacon Prescriptions (see DCA Inc.), Southington, CT

Bedford Pharmacy, Inc. (dba Mytilini Enterprises LLC), Bedford, NH

Untitled Letter Issued 10/4/2019 (PDF-100KB)
Firm response to 483 dated 09/22/2017 (PDF - 1MB)
483 Issued 08/17/2017 (PDF - 953KB)
Warning Letter (05/18/2016)
483 Issued 08/28/2015 (PDF - 776KB)

Bella Pharmaceuticals, Inc.

Warning Letter (02/11/2019)
Firm Press Release: Bella Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of All Sterile Drug Products Due to Lack of Sterility Assurance (8/18/2017)
483 Issued 07/28/2017 (PDF - 1.9 MB)
483 Issued 07/25/2017 (PDF - 1.9 MB)

Bellevue Pharmacy Solutions, St Louis, MO

Warning Letter (01/14/2008)

Belmar Pharmacy, (see BSO LLC), Lakewood, CO

Best Value Drug, (see Farmville Discount Drug, Inc.), Farmville, NC

Bhaumik Diversified LLC dba Texas St ar Pharmacy, Dallas, TX

483 issued 11/3/2021 (PDF - 1.5MB)

Biomed PA Inc. (dba Soleo Health), Sharon Hill, PA

State Referral Letter Issued 05/14/2018 (PDF - 75KB)
FMD-145 Letter Issued 08/30/2017 (PDF - 49KB)
483 Issued 07/06/2017 (PDF - 280KB)

Bioscrip Infusion Services, (see HomeChoice Partners, Inc.), Augusta, GA

Bioscrip Infusion Services, (see InfuScience, Inc.), Chantilly, VA

BioScrip Pharmacy (NY), Inc., Lake Success, NY

Referral to the New York State Board of Pharmacy Issued 11/16/2017 (PDF - 93KB)
483 Response Dated 10/10/2014 (PDF - 1.3MB)
483 Issued 09/19/2014 (PDF - 1.9MB)

Blount Discount Pharmacy, Inc., Alcoa, TN

Untitled Letter Issued 06/17/2021 (PDF - 1MB)
483 Issued 02/13/2020 (PDF - 1.55MB)

Blue Ridge Pharmacy and Compounding Center, Raleigh, NC

Warning Letter (04/30/2014)
483 Issued 10/23/2013 (PDF – 589KB)

BMD Skincare, Inc., Canoga Park, CA

483 Issued 03/05/2019 (PDF - 15.6MB)

Bond Pharmacy, Inc. (dba Advanced Infusion Solutions), Clinton, MS

Referral Letter to the Mississippi Board of Pharmacy Issued 08/02/2016 (PDF - 407KB)
483 Response Dated 11/16/2015 (PDF - 1.3MB)
483 Issued 10/27/2015 (PDF - 945KB)

Bond Pharmacy, Inc. (dba Advanced Infusion Solutions), Ridgeland, MS

FMD-145 Issued 04/20/2018 (PDF - 45KB)
Warning Letter Response Dated 03/23/2017
Warning Letter (03/01/2017)
483 Response Dated 11/16/2015 (PDF - 1.3MB)
483 Issued 10/27/2015 (PDF - 1.7MB)

Boothwyn Pharmacy LLC, Kennett Square, PA

483 Issued 06/16/2017 (PDF - 736KB)

Botrosons Pharmaceutical Inc., (dba Tower Pharmacy and Compounding), Mission Viejo, CA

483 Issued 10/20/2021 (PDF - 201KB)
483 Issued 09/19/2019 (PDF - 1.05MB)

BPI Labs, LLC, Largo, FL

483 Issued 04/30/2021 (PDF - 2.17MB)

brandMD Skin Care, (see TSDR Pharmacy, Inc.), Chatsworth, CA

Brookfield Pharmacy, Brookfield, CT.

483 Issued 06/28/2017 (PDF - 2.1 MB)

Brookfield Medical/Surgical Supply, Inc., Brookfield, CT

483 Issued 12/21/2018 (PDF - 1.12MB)
Amended 483 Issued 04/18/2017 (PDF - 859KB)
483 Issued 04/18/2017 (PDF - 872KB)
Warning Letter (07/05/2016)
483 Issued 04/09/2015 (PDF - 1.7MB)

Brookfield Prescription Center, Inc. (dba MD Custom Rx), Brookfield, WI

Warning Letter (05/02/2014)
483 Issued 12/13/2013 (PDF – 5MB)

Brown's Compounding Center, Inc., Englewood, CO

Warning Letter (08/17/2016)
483 Issued 04/27/2015 (PDF - 604KB)
483 Issued 08/11/2014 (PDF - 580KB)

BSO LLC (dba Belmar Select Outsourcing), Lakewood, CO

483 Issued 03/11/2021 (PDF - 1.1MB)
FMD-145 Letter Issued 6/22/2020 (PFD-60KB)
483 Issued 09/20/2019 (PDF - 265KB)
Untitled Letter Issued 01/10/2019 (PDF - 698KB)
State Referral Letter issued 12/05/2016 (PDF - 82KB)
483 Issued 09/02/2016 (PDF - 457KB)
483 Issued 06/18/2015 (PDF - 1.1MB)

Buderer Drug Company Inc. Avon, OH

Referral Letter to the Ohio State Board of Pharmacy Issued 10/29/2019 (PDF - 126KB)
FMD-145 Letter Issued 10/21/2019 (PDF - 106KB)
483 Response Letter Dated 03/15/2019 (PDF - 679KB)
483 Issued 02/14/2019 (PDF - 268KB)

Buderer Drug Company Inc. Perrysburg, OH

Referral Letter to the Ohio State Board of Pharmacy Issued 05/01/2019 (PDF - 98KB)
Warning Letter CloseOut (05/01/2019)
FMD-145 Letter Issued 05/01/2019 (PDF - 105KB)
483 Issued 07/24/2017 (PDF - 257KB)
Warning Letter (09/20/2016)
483 Issued 01/04/2016 (PDF - 402KB)

Buffalo Pharmacies, Inc., East Amherst, NY

State Referral Letter Issued 9/16/2019 (PDF-127-KB)
FMD-145 Letter Issued 9/16/2019 (PDF-105KB)
483 Issued 07/26/2018 (PDF - 157KB)
Warning Letter (12/13/2017)
483 Issued 06/23/2017 (PDF - 690KB)

Burklow Pharmacy, Inc., Pace, FL

FMD-145 Letter Issued 04/05/2017 (PDF - 169KB)
Referral Letter to the Florida Board of Pharmacy Issued on 01/31/17 (PDF - 193KB)
483 Issued 03/04/2015 (PDF - 53KB)

California Pharmacy and Compounding Center, Newport Beach, CA

Amended 483 Issued 12/18/2018 (PDF - 196KB)
483 Issued 04/21/2017 (PDF - 833KB)
483 Issued 08/31/2016 (PDF - 919KB)
Warning Letter (06/17/2015)
483 Issued 10/17/2014 (PDF - 544KB)
483 Issued 08/25/2014 (PDF - 2.8MB)

California Specialty Pharmacy, Inc., Whittier, CA

483 Issued 05/17/2019 (PDF - 397KB)

Cantrell Drug Company, Little Rock, AR

483 Issued 08/22/2018 (PDF - 466KB)
483 issued 03/22/2018 (PDF - 1.3MB)
FDA Press Release: Federal Judge Enters Consent Decree Against Cantrell Drug Company (04/19/2018)
FDA Press Release: FDA Alerts Health Care Professionals and Patients not to Use Compounded Drugs from Cantrell Drug Company; Agency Seeks Action to Stop Production and Distribution (03/01/2018)
Firm Press Release: Cantrell Drug Company Issues Voluntary Nationwide Recall of All Sterile Drug Products Due to Lack of Sterility Assurance (07/25/2017)
483 Issued 06/29/2017 (PDF - 3MB)
Firm Press Release: Sterile Drug Products by Cantrell Drug Company: Recall of Select Sterile Drug Products Due to Lack of Sterility Assurance (11/18/2016)
Second Amended 483 Issued 10/14/2016 (PDF - 4.5MB)
Amended 483 Issued 10/14/2016 (PDF - 4.5MB)
483 Issued 10/14/2016 (PDF - 4.5MB)
Company Response Letter 02/10/2015
Warning Letter (01/21/2015)
Amended 483 Issued 11/4/2013 (PDF - 6.5MB)

Cape Drugs, (see Valgene Incorporated), Annapolis, MD

Carepoint Healthcare, LLC (dba Carepoint Pharmacy), Schaumburg, IL

FMD-145 Letter Issued 06/19/2018 (PDF - 232KB)
State Referral Letter Issued 06/19/2018 (PDF - 181KB)
483 Issued 08/24/2017 (PDF - 947KB)

Care Solutions, Inc., Nashville, TN

FMD-145 Issued 08/02/2018 (PDF - 48KB)

Carlton’s Dunwoody Pharmacy Corp, (dba Concord, Inc.), Dunwoody, GA

Referral Letter to the Georgia State Board of Pharmacy Issued 11/18/2019 (PDF - 68KB)
FMD-145 Letter Issued 11/18/2019 (PDF - 66KB)
483 Issued 04/12/2019 (PDF - 79KB)
Warning Letter (08/20/2017)
483 Issued 01/13/2016 (PDF - 714KB)

Cascade Specialty Pharmacy, (see Poulsbo Compounding Pharmacy, LLC), Poulsbo, WA

Central Admixture Pharmacy Services, Inc. (CAPS), Homewood, AL

483 Issued 03/07/2013 (PDF - 600KB)

Central Admixture Pharmacy Services, Inc., Phoenix, AZ

483 Issued 02/25/2022 (PDF - 2.1MB)
FMD-145 Letter Issued 06/03/2020 (PDF - 57KB)

Central Admixture Pharmacy Services, Inc. Irvine, CA

FMD-145 Letter Issued 05/03/2017 (PDF - 447KB)
483 Issued 02/05/2016 (PDF - 448KB)

Central Admixture Pharmacy Services, Inc. (CAPS), San Diego, CA

FMD-145 Letter Issued 05/27/2020 (PDF - 72KB)
483 Issued 09/11/2018 (PDF - 792KB)
Warning Letter (08/18/2016)
483 Issued 08/08/2014 (PDF - 1.5MB)

Central Admixture Pharmacy Services (CAPS), Wallingford, CT

Referral to the Connecticut State Board of Pharmacy Issued 07/12/2017 (PDF - 52KB)
483 Issued 01/29/2016 (PDF - 1.8MB)
483 Issued 02/19/2013 (PDF - 8MB)

Central Admixture Pharmacy Services, Inc., (CAPS), Chicago, IL

483 Issued 02/22/2013 (PDF - 974KB)

Central Admixture Pharmacy Services, Inc. (CAPS), Harahan, LA

483 Issued 05/24/2021 (PDF - 731KB)

Central Admixture Pharmacy Services, Inc. (CAPS), Woburn, MA

483 Issued 02/20/2014 (PDF - 1.9MB)
483 Issued 01/29/2013 (PDF - 11.7MB)

Central Admixture Pharmacy Services, Inc., (CAPS), Livonia, MI

Referral Letter to the Michigan Board of Pharmacy Issued 03/22/2017 (PDF - 461KB)
483 Issued 12/04/2015 (PDF - 922KB)
483 Issued 06/25/2014 (PDF - 928KB)
483 Issued 02/28/2013 (PDF - 790KB)

Central Admixture Pharmacy Services, Inc., (CAPS), Kansas City, MO

483 Issued 02/28/2013 (PDF - 697KB)

Central Admixture Pharmacy Services Inc. Valley View, OH

Referral Letter to the Ohio State Board of Pharmacy Issued 08/09/17 (PDF - 101KB)
483 Issued 01/21/2016 (PDF - 876KB)

Central Admixture Pharmacy Services, Inc. (CAPS), Allentown, PA

FMD-145 Letter Issued 06/17/2020 (PDF - 74KB)
483 Issued 08/22/2018 (PDF - 2.1MB)
483 Issued 09/19/2016 (PDF - 898KB)
Warning Letter (08/19/2016)
483 Issued 02/11/2015 (PDF - 888KB)
483 Issued 06/11/2014 (PDF - 2.1MB)

Central Admixture Pharmacy Services, Inc. (CAPS), Horsham, PA

Referral Letter to the Pennsylvania State Board of Pharmacy Issued 01/17/17 (PDF - 335KB)
483 Issued 11/20/2015 (PDF - 595KB)

Central Illinois Compounding, Inc. (dba Preckshot Professional Pharmacy), Peoria Heights, IL

Amended 483 issued 08/10/2018 (PDF - 752KB)
483 issued 08/10/2018 (PDF - 723KB)
483 Issued (9/19/2017)
Warning Letter (09/02/2016)
483 Issued 05/14/2015 (PDF - 910KB)

CFP Acquisitions, Inc, Tulsa, OK

483 Issued 01/18/2022 (PDF - 706KB)
483 Issued 07/11/2018 (PDF - 511KB)

Chastains, Inc., (dba Owl Tri State Pharmacy), Clarkston, WA

483 Issued 08/27/2021 (PDF - 345KB)

Chen Shwezin, Inc., (dba Park Compounding Pharmacy), Westlake Village, CA

FMD-145 Letter Issued 07/20/2020 (PDF - 62KB)
Referral Letter to the California State Board of Pharmacy Issued 07/20/2020 (PDF - 58KB)
483 Issued 04/03/2018 (PDF - 778KB)
Warning Letter (03/15/2017)
FDA Statement: FDA Alerts Health Care Professionals and Patients not to Use Sterile Drug Products from Chen Shwezin Inc., dba Park Compounding Pharmacy (10/2/2015)
483 Issued 09/11/2015 (PDF - 1.4MB)

Cincinnati Specialty Pharmacy LLC, West Chester, OH

State Referral Letter Issued 07/10/2017 (PDF - 61KB)
483 Issued 09/26/2016 (PDF - 533KB)

Civic Center Pharmacy, Scottsdale, AZ

483 Issued 03/30/2017 (PDF - 469KB)
Warning Letter (08/20/2015)
483 Response Dated 10/10/2014 (PDF - 2.2MB)
483 Issued 10/09/2014
Warning Letter (12/16/2008)

Claremore Compounding Center, Inc., Claremore, OK

Untitled Letter Issued 08/21/2020 (PDF - 1.63MB)
483 Issued 01/24/2020 (PDF - 3.76MB)

Clark Professional Pharmacy, LLC, Ann Arbor, MI

Referral Letter to the Michigan Board of Pharmacy Issued 09/09/16 (PDF - 429KB)
483 Response Dated 02/11/2016 (PDF - 2.3MB)
483 Issued 01/29/2016 (PDF - 225KB)

Clinical Apothecaries, Medina, OH

Referral Letter to the Ohio Board of Pharmacy Issued 05/30/2014 (PDF - 1.1MB)
483 Issued 11/20/2013 (PDF - 660KB)

Clinical Specialties Compounding Pharmacy, Augusta, GA

Warning Letter (06/27/2014)
483 Issued 04/02/2013 (PDF - 5.4MB)
FDA Press Release: FDA Alerts Health Care Providers and Patients of the Nationwide Recall of All Lots of Sterile Products Distributed by Clinical Specialties Compounding Pharmacy (03/21/2013)
Firm Press Release: Clinical Specialties Compounding Pharmacy Recalls All lots of Sterile Products Repackaged and Distributed by Clinical Specialties Compounding Due to Lack of Sterility Assurance (03/20/2013)

CMC Enterprise Pharmacy, Charlotte, NC

FMD-145 Letter Issued 07/17/2020 (PDF - 190KB)
Warning Letter (06/04/2020)

Coastal Meds, LLC., Biloxi, MS

FMD-145 Letter Issued 11/05/2019 (PDF - 67KB)
Referral Letter to the Mississippi State Board of Pharmacy Issued 11/05/2019 – Shutdown Letter (PDF - 97KB)
FDA Statement: FDA Alerts Health Care Professionals to Voluntary Nationwide Recall of All Sterile Products from Coastal Meds (4/13/18)
483 Issued 04/06/2018 (PDF - 1.2MB)
Warning Letter (06/22/2016)
483 Issued 09/23/2015 (PDF - 1.1MB)
483 Issued 11/10/2014 (PDF - 691KB)

Coast Quality Pharmacy, LLC, Tampa, FL

483 Issued 05/09/2019 (PDF - 1.16MB)
483 Issued 05/07/2018 (PDF - 2.6MB)

College Pharmacy Incorporated, Colorado Springs, CO

483 Issued 01/17/2018 (PDF - 1MB)
Warning Letter (08/15/2016)
483 Issued 05/28/2015 (PDF - 1MB)
483 Issued 03/15/2013 (PDF - 1.3MB)

Colonia Care Pharmacy, Colonia, NJ

483 Issued 08/17/2021 (PDF - 718KB)
483 Issued 04/29/2019 (PDF - 601KB)
Warning Letter (09/20/2017)
483 Response Dated 05/05/2016 (PDF - 969KB)
483 Issued 04/15/2016 (PDF - 708KB)

Columbia River Pharmacy, LLC, (dba Malley's Compounding Pharmacy), Richland, WA

483 Issued 08/16/2019 (PDF - 281KB)

Complete Pharmacy and Medical Solutions, LLC, Miami Lakes, FL

Compound Care Pharmacy, Louisville, KY

FMD-145 Letter Issued 06/04/2020 (PDF - 106KB)
483 Issued 05/16/2019 (PDF - 169KB)

Compounded Solutions in Pharmacy LLC, Monroe CT

483 Issued 07/27/2021 (PDF - 966KB)
Warning Letter (09/18/2017)
483 Issued 03/03/2017 (PDF - 567KB)

Compounding Pharmacies of Louisiana Inc. (dba Professional Arts Pharmacy), Lafayette, LA

Closeout Letter Issued 10/17/2016 (PDF - 208KB)

Conrad-Marr Drug, (see McAlister Drug Corporation), Yukon, OK

Conversio Health, (see Integrated Health Concepts Inc.), San Luis Obispo, CA

Coram Healthcare Corp. of Indiana, Crown Point, IN

FMD-145 Letter Issued 03/07/2019 (PDF - 89KB)
Facility Closure Letter 05/29/2018 (PDF - 125KB)
483 Firm Response Dated 05/16/2017 (PDF - 951KB)
483 Issued 04/26/2017 (PDF - 503KB)
Warning Letter (08/11/2015)
483 Issued 12/16/2014

Cortez Drugs, (see A Chem Rx, LLC), Brooksville, FL

Crawford's Professional Drugs, Inc., (dba Diket's Professional Drugs, Inc.), Laurel, MS

Referral Letter to the Mississippi Board of Pharmacy Issued 06/27/2019 (PDF - 59KB)
FMD-145 Letter Issued 06/27/2019 (PDF - 64KB)
483 Issued 11/29/2018 (PDF - 574KB)

CRC Pharmacy, Roswell, GA

Referral Letter to the Georgia State Board of Pharmacy Issued 02/15/2017 (PDF - 195KB)

Creative Compounds, (see Oregon Compounding Centers, Inc.), Wilsonville, OR

Crosby’s Drugs Inc., Columbus, OH

Warning Letter (11/30/2017)
483 Issued 09/16/2016 (PDF - 612KB)

Crowder's Institutional Pharmacy LLC., dba Crowder's Long-Term Care Pharmacy, Bedford, IN

Referral Letter to the Indiana State Board of Pharmacy Issued 10/02/2019 (PDF - 579KB)
FMD-145 Letter Issued 10/02/2019 (PDF - 513KB)

CSRX Inc., (dba Rushmore Compounding Pharmacy), Rapid City, SD

FMD-145 Letter Issued 02/19/2019 (PDF - 66KB)
Untitled Letter Issued 12/20/2017 (PDF - 314KB)

Curexa, (see EHT Pharmacy LLC), Egg Harbor Township, NJ

Customceutical Compounding, LLC, Phoenix, AZ

Warning Letter (08/25/2020)
483 Issued 03/08/2019 (PDF - 957KB)

Custom Compounding Center, Little Rock, AR

Referral Letter to the Arkansas State Board of Pharmacy Issued 10/28/2020 (PDF - 435KB)
483 Issued 06/04/2019 (PDF - 196KB)
Warning Letter (03/16/2016)
483 Issued 04/09/2015 (PDF - 603KB)

Custom Compounding Centers, LLC, Los Alamitos, CA

Referral Letter to the California State Board of Pharmacy Issued 12/14/2015 (PDF - 120KB)
483 Response Dated 10/17/2014 (PDF - 637KB)
483 Response Dated 10/09/2014 (PDF - 225KB)
483 Response Dated 09/18/2014 (PDF - 844KB)
483 Issued 08/28/2014 (PDF - 457KB)
Warning Letter (05/15/2013)
483 Issued 12/13/2012 (PDF - 577KB)

Custom Meds Inc. Inverness, FL

Closeout Letter Issued 07/21/2016 (PDF - 388KB)
483 Issued 03/25/2016 (PDF - 429KB)

Custom RX LLC, Wichita, KS

Warning Letter (10/18/2018)
483 Issued 08/15/2017 (PDF -331KB)

Custom RX LLC (dba Custom RX Compounding Pharmacy), Richfield, MN

483 Issued 08/28/2014 (PDF - 775KB)

D&D Pharma, LLC (dba MedScript Compounding Pharmacy), Noblesville, IN

FMD-145 Letter Issued 03/05/2020 (PDF - 116KB)
483 Issued 07/17/2019 (PDF - 458KB)

D&S Enterprises, LLC (dba Miller’s Health Mart Pharmacy), Vero Beach, FL

FMD-145 Letter Issued 03/16/2018 (PDF - 63KB)
483 Issued 08/09/2017 (PDF - 205KB)

DCA Inc. (dba Beacon Prescriptions), Southington, CT

Warning Letter (6/1/2017)
4 83 Issued 10/25/2016 (PDF - 816KB)

Delta Pharma, Inc., Ripley, MS

FDA Press Release: Federal judge enters consent decree against Delta Pharma (06/08/2018)
483 Issued 02/23/2017 (PDF - 1.4MB)
483 Issued 05/24/2016 (PDF - 1013KB)
Warning Letter (12/09/2014)
483 Issued 10/02/2013 (PDF - 857KB)

Denson's Specialty Pharmacy, (see Wellcare Rx Investments LLC), Wheaton, IL

Denver Solutions, LLC (dba Leiter's Health), Englewood, CO

483 Issued 07/18/2019 (PDF - 606KB)
FMD-145 Letter Issued 10/18/2018 (PDF - 54KB)
483 Issued 02/23/2018 (PDF - 654KB)

Designer Drugs, (see The Wellness Center Pharmacy, Inc.), Chattanooga, TN

Diabetes Corporation of America, Franklin, TN

State Referral Letter Issued 02/19/2018 (PDF - 71KB)
FMD-145 Letter Issued 02/19/2018 (PDF - 63KB)
483 Issued 06/15/2017 (PDF - 406 KB)
Warning Letter (06/03/2016)
483 Issued 08/20/2015 (PDF - 741 KB)

Diamond Drugs, Inc., (dba Diamond Pharmacy Services), Indiana, PA

FMD-145 Letter Issued 07/20/2018 (PDF - 72KB)
State Referral Letter Issued 07/20/2018 (PDF - 70KB)
483 Issued 07/21/2017 (PDF - 197KB)

Diamond Pharmacy, LLC, Houston, TX

DOJ Press Release: Leader of $17 Million Health Insurance Fraud Scheme Ordered to Prison (July 27, 2017)
483 Issued 05/15/2015 (PDF - 1.8 MB)

Dignity Health- Northridge Hospital Medical Center, Northridge, CA

483 Issued 11/07/2017 (PDF - 1.2MB)
Warning Letter (12/13/2016)
483 Issued 03/11/2016 (PDF - 1.1MB)

Diket's Professional Drugs, Inc., (see Crawford's Professional Drugs, Inc.), Laurel, MS

Diplomat Pharmacy, Inc. (dba Diplomat Specialty Pharmacy), Flint, MI

State Referral Letter Issued 02/11/2019 (PDF - 75KB)
FMD-145 Letter Issued 02/11/2019 (PDF - 70KB)
483 Issued 11/17/2017 (PDF - 722KB)

Diversified Pharmacy Inc., (dba University Compounding Pharmacy), Troy, MI

FMD-145 Letter Issued 11/01/2018 (PDF - 69KB)
State Referral Letter Issued 11/01/2018 (PDF - 109KB)
483 Issued 06/19/2017 (PDF - 431KB)
Warning Letter (02/26/2016)
483 Response Dated 12/02/2014 (PDF - 1.6MB)
483 Issued 11/13/2014 (PDF - 869KB)

DNA Pharmacy Services, Inc. (dba Palm Beach Compounding), Jupiter, FL

483 Issued 05/23/2017 (PDF - 33KB)
483 Issued 08/13/2014 (PDF - 251KB)

Dorneyville Pharmacy, Allentown, PA

FMD-145 Letter Issued 6/22/2020 (PDF-103KB)
483 Issued 09/28/2018 (PDF - 223KB)
Warning Letter (02/07/2017)
483 Issued 01/07/2016 (PDF - 2.1MB)

Dougherty's Pharmacy, Dallas, TX

FMD-145 Letter Issued 05/18/2020 (PDF - 70KB)
Referral Letter to the Texas State Board of Pharmacy Issued 05/18/2020 (PDF - 75KB)
483 Issued 07/01/2019 (PDF - 1.28MB)
483 Issued 12/29/2015 (PDF - 2.1MB)
Warning Letter (05/12/2017)

Downing Labs, LLC, (formerly NuVision Pharmacy), Dallas, TX

FMD-145 Letter Issued 08/06/2019 (PDF - 74KB)
483 Issued 11/19/2018 (PDF - 416KB)
FDA Press Release: Federal Judge Enters Consent Decree Against Downing Labs (01/11/2016)
Firm Press Release: Downing Labs, LLC Issues Voluntary Nationwide Recall of All Sterile Compounded Products Due to Lack of Sterility Assurance (10/20/2015)
483 Issued 10/09/2015 (PDF - 8.9MB)
FDA Requested Recall Letter Issued 09/09/2014 (PDF – 941KB)
FDA Press Release: FDA Reminds Health Care Professionals and Consumers not to Use Sterile Products from Downing Labs/NuVision Pharmacy of Texas (09/09/2014)
483 Response Dated 08/20/2014 (PDF - 4.2MB)
483 Response Dated 08/06/2014 (PDF - 4MB)
FDA Statement: FDA Alerts Health Care Professionals not to Use Sterile Drugs from Downing Labs (aka NuVision Pharmacy) (07/18/2014)
483 Issued 07/16/2014 (PDF - 2.1MB)
FDA Press Release: FDA Reminds Health Care Providers not to Use Sterile Products from NuVision Pharmacy (08/16/2013)
FDA Requested Recall Letter Issued 07/26/2013 (PDF – 862KB)
FDA Press Release: FDA Expands Alert to Health Care Providers About Lack of Sterility Assurance of All Sterile Drug Products from NuVision Pharmacy (05/18/2013)
483 Issued 04/17/2013 (PDF - 1.2MB)
Firm Press Release: NuVision Pharmacy Recalls All Lots of All Lyophilized Products Compounded by NuVision Pharmacy Due to Sterility Assurance Concerns (04/15/2013)
FDA Press Release: FDA Issues Alert About Lack of Sterility Assurance of Drug Products from ApotheCure, Inc. and NuVision Pharmacy and of Forthcoming Recall (04/15/2013)

D.R. Pharmacy, Inc., Midland, TX

483 Issued 03/06/2015 (PDF - 647KB)

Drug Crafters, L.P., Frisco, TX

State Referral Letter Issued 02/11/2019 (PDF - 67KB)
483 Issued 07/11/2018 (PDF - 340 KB)

Drug Depot Inc. (dba APS Pharmacy), Palm Harbor, FL

FDA Press Release: FDA alerts customers to voluntary recall of compounded drugs due to sterility issues by Drug Depot, LLC, dba APS Pharmacy (04/26/2022)
FMD-145 Letter Issued 09/20/2019 (PDF - 63KB)
483 Issued 07/13/2018 (PDF - 272KB)
Warning Letter (12/15/2016)
483 Issued 01/22/2016 (PDF - 1.7MB)

Drugs are Us, Inc. (dba Hopewell Pharmacy), Hopewell, NJ

Referral Letter to New Jersey State Board of Pharmacy Issued 02/21/2014 (PDF - 1.3MB)
483 Response Dated 02/21/2014
483 Issued 03/21/2013 (PDF - 1.5MB)
Warning Letter (09/28/2009)

Duren's Health Mart Pharmacy, Waynesboro, TN

483 Issued 11/14/2018 (PDF - 358KB)

Dynalabs LLC, Saint Louis, MO

483 Issued 09/26/2019 (PDF - 2.07MB)

Eagle New York, Garfield, NJ

Warning Letter (12/06/2013)

Eagle Pharmacy, Inc., Hoover, AL

483 Issued 08/12/2021 (PDF - 985KB)
483 Issued 05/18/2018 (PDF - 692KB)
Warning Letter (10/13/2016)
483 Issued 08/21/2015 (PDF - 1.2MB)

East Marietta Drug Company, Marietta, GA

FMD-145 Letter Issued 05/19/2020 (PDF - 83KB)
Referral Letter to the Georgia State Board of Pharmacy Issued 05/19/2020 (PDF - 88KB)
483 Issued 08/23/2019 (PDF - 2.08MB)

Eastern Pharmacy, Inc., Ocala, FL

Warning Letter (10/29/2014)
483 Issued 02/04/2014 (PDF - 516KB)

Eastern States Compounding Pharmacy, (see Northern New England Compounding Pharmacy), Littleton, NH

Edge Pharmacy Services, LLC, Colchester, VT

DOJ Press Release District Court Enjoins Vermont Pharmacy from Distributing Drugs Not Made in Compliance with FDCA (06/13/2022)
483 Issued 12/01/2021 (PDF - 6.45MB)
483 Issued 03/30/2020 (PDF - 3.6MB)
483 Issued 03/08/2018 (PDF - 3.5MB)
483 Issued 01/20/2017 (PDF - 717KB)
Warning Letter (11/12/2015)
483 Issued 08/20/2014 (PDF - 923KB)

EHT Pharmacy LLC, (dba Curexa), Egg Harbor Township, NJ

483 Issued 10/09/2020 (PDF - 743KB)
483 Issued 09/27/2018 (PDF - 276KB)

Elkhart Pharmacy, Elkhart, TX

Warning Letter (05/08/2017)
483 Issued 12/21/2015 (PDF - 765KB)

Empower Clinic Services, LLC, Houston, TX

Warning Letter (10/15/2021)
483 Issued 03/06/2020 (PDF - 1.02MB)
Untitled Letter Issued 07/22/2019 (PDF - 106KB)
483 Issued 01/24/2018 (PDF - 650KB)
483 Issued 11/25/2015 (PDF - 971KB)
Warning Letter (05/25/2017)

Enclara Pharmacia Inc., Sharon Hill, PA

Warning Letter (03/29/2017)
483 Issued 06/06/2016 (PDF - 372KB)

Essential Pharmacy Compounding, Omaha, NE

483 Issued (7/27/2017)
Warning Letter (03/10/2016)
483 Issued 05/22/2015 (PDF - 1.2MB)

Essential Wellness Pharma, (see Kalman Health & Wellness Inc.), Peoria, IL

Everwell Specialty Pharmacy, Pensacola, FL (see Pensacola Apothecary Inc.)

Exela Pharma Sciences, LLC, Lenoir, NC

483 Issued 07/18/2019 (PDF - 1.63MB)
FMD-145 Letter Issued 11/29/2018 (PDF - 38KB)
483 Issued 09/28/2017 (PDF - 665KB)
Firm Press Release: Exela Pharma Sciences, LLC Issues Voluntary Nationwide Recall of Ibuprofen Lysine Injection, 20 Mg/2 Ml (10 Mg/Ml) Due to Particulate Matter (02/08/2017)
Untitled Letter (04/28/2016)
483 Issued 11/21/2014 (PDF - 406KB)

Fagron Compounding Services LLC (dba Fagron Sterile Services), Wichita, KS

483 Issued 06/21/2019 (PDF - 1.87MB)
Firm Press Release: Fagron Sterile Services Issues Voluntary Nationwide Recall of Neostigmine Methylsulfate 1mg/mL, 5mg per 5mL and Neostigmine Methylsulfate 1mg/mL, 3mg per 3mL, in a 5mL syringe Due to Mislabeling (06/29/2018)
Warning Letter (11/28/2017)
Firm Press Release: Fagron Sterile Services Issues Voluntary Nationwide Recall of Succinylcholine Chloride Due to Potential For Lack of Sterility Assurance (06/23/2017)
483 Issued 09/21/2016 (PDF - 680KB)
FDA Statement: FDA alerts compounding pharmacies of a nationwide voluntary recall of Syrspend SF and Syrspend SF Grape suspending agents from Fagron Inc., due to microbial contamination with yeast (02/10/2016)

Fairview Compounding Pharmacy, Minneapolis, MN

FMD-145 Letter Issued 04/29/2019 (PDF - 95KB)
Referral Letter to the Minnesota State Board of Pharmacy Issued 04/29/2019 (PDF - 122KB)
Firm Response Dated 05/08/2018 (PDF - 738KB)
483 Issued 04/18/2018 (PDF - 446KB)

Fallon Wellness Pharmacy, LLC, Latham, NY

483 Issued 12/06/2016 (PDF - 1.6MB)
Warning Letter (02/01/2016)
483 Issued 03/10/2015 (PDF - 1MB)

Family Pharmacy of Statesville, Inc., Statesville, NC

483 Issued 03/11/2022 (PDF - 923KB)
Warning Letter (11/06/2020)
483 Issued 02/12/2020 (PDF - 878KB)

Far Hills Pharmacy, (see Pharmaview, Inc.), Bedminster, NJ

Farmacia Le Salud Inc., Caguas, PR

Warning Letter (03/26/2008)

Farmakeio Outsourcing LLC, Southlake, TX

FDA Statement: FDA warns patients and health care professionals not to use sterile products from North American Custom Laboratories LLC, dba FarmaKeio Superior Custom Compounding (3/30/2022)
Warning Letter (07/29/2021)
483 Issued 10/30/2019 (PDF - 2.76MB)

Farmville Discount Drug, Inc., (dba Best Value Drug), Farmville, NC

Warning Letter (07/09/2019)

FH Investments Inc., (dba Asteria Health), Birmingham, AL

483 Issued 07/10/2018 (PDF - 439KB)

First Call IV Pharmacy, LLC, Kenner, LA

FMD-145 Letter issued 05/14/2018 (PDF - 47KB)
State Referral Letter issued 05/14/2018 (PDF - 55KB)
483 Issued 08/02/2017 (PDF - 550KB)

First Pharma Associates LLC (dba Riverpoint Pharmacy), Spokane, WA

483 Issued 03/03/2021 (PDF - 381KB)
483 Issued 06/07/2019 (PDF - 1MB)
Warning Letter (09/12/2017)
483 Response Dated 01/09/17 (PDF - 396KB)
483 Issued 12/16/2016 (PDF - 542KB)

First Royal Care Co. LLC, (dba Red Mountain Compounding Pharmacy), Mesa, AZ

483 Issued 08/11/2021 (PDF - 1.7MB)
Warning Letter (09/08/2020)
483 Issued 06/14/2019 (PDF - 1.37MB)

Flourish Integrative Pharmacy, LLC, Oklahoma City, OK

FMD-145 Letter Issued 04/15/2020 (PDF - 121KB)
483 Issued 12/19/2018 (PDF - 341KB)

Foothills Professional Pharmacy, Ltd., Phoenix, AZ

483 Issued 10/01/2021 (PDF - 501KB)
Warning Letter (09/09/2020)
483 Issued 10/24/2018 (PDF - 1.1MB)

Foundation Care LLC, Earth City, MO

Referral Letter to Missouri Board of Pharmacy Issued 02/26/2014 (PDF - 396KB)
483 Response Dated 04/09/2013 (PDF - 1020KB)
483 Issued 03/19/2013 (PDF - 867KB)

Franck's Compounding Lab (see Franck's Lab, Inc.), Ocala, FL

Franck's Lab, Inc. (dba Franck's Compounding Lab), Ocala, FL

FDA Press Release: Federal judge enters order of permanent injunction against Paul W. Franck (4/29/2016)
Warning Letter (07/09/2012)
Firm Press Release: All Sterile Human and Veterinary Prescriptions Distributed by Franck's Pharmacy from November 21, 2011 to May 21, 2012 (05/25/2012)
Firm Press Release: Notice of Recall - Triamcinolone acetonide P.F. 80mg/ml (05/02/2012)
FDA Statement: Updated: FDA Issues Second Warning to Physicians about Certain Compounded Drugs from Franck's (04/20/2012)
Firm Press Release: Notice of Recall (03/31/2012)
FDA Statement: FDA Warns Physicians about Using Brilliant Blue G for Eye Surgery (03/19/2012)
Firm Press Release: Recall of Brilliant Blue G Urgent Product Recall - Immediate Action Required (03/09/2012)

Franck's Lab, Inc. (dba Trinity Care Solutions), Ocala, FL

483 Issued 05/23/2014 (PDF - 856KB)

Freedom Fertility Pharmacy, (see Lynnfield Drug, Inc.), Byfield, MA

Freedom Pharmacy, (see HHCS Pharmacy, Inc.), Orlando, FL

Fresenius Kabi Compounding, LLC, Canton, MA

FMD-145 Letter Issued 04/22/2020 (PDF - 88KB)
483 Issued 12/04/2018 (PDF - 2.9MB)

Front Door Pharmacy, LLC, (dba Pure Pharmacy), Houston, TX

Warning Letter (07/01/2020)
483 Issued 03/18/2019 (PDF - 1MB)

Front Range Laboratories, Incorporated, Loveland, CO

483 Issued 03/20/2020 (PDF - 589KB)

Fusion IV Pharmaceuticals Inc. (dba Axia Pharmaceuticals), Los Angeles, CA

483 Issued 12/20/2019 (PDF - 3.5MB)
Warning Letter (02/21/2018)
Second Amended 483 Issued 03/23/2017 (PDF - 1.4MB)
Amended 483 Issued 03/23/2017 (PDF - 1.4MB)
483 Issued 03/23/2017 (PDF - 1.5MB)

FVS Holdings, Inc. (dba Green Valley Drugs), Henderson, NV

Warning Letter (08/30/2013)
Firm Press Release: Green Valley Drugs Announces Voluntary Nationwide Recall of All Lots of All Sterile Products Compounded, Repackaged, and Distributed by Green Valley Drugs Due to Quality Control Concerns (04/05/2013)
483 Issued 03/15/2013 (PDF - 4.9MB)

Garda Rx LLC., Apollo, PA

FMD-145 Letter Issued 05/07/2018 (PDF - 71KB)
State Referral Letter Issued 05/07/2018 (PDF - 72KB)
483 Issued 06/06/2017 (PDF - 47 KB)

Geneva Woods Pharmacy, Anchorage, AK

Referral Letter to the Alaska State Board of Pharmacy dated 02/18/2020 (PDF - 98KB)
FMD-145 Letter Issued 02/18/2020 (PDF - 79KB)
Referral Letter to the Alaska State Board of Pharmacy dated 02/06/2020 (PDF - 72KB)
FMD-145 Letter Issued 02/06/2020 (PDF - 62KB)
483 Issued 04/16/2019 (PDF - 411KB)
483 Issued 12/07/2018 (PDF - 1MB)

Gipsco Investment Corp. (dba Lee Silsby Compounding Pharmacy), Cleveland Heights, OH

Warning Letter (07/10/2018)
483 Issued 06/09/2017 (PDF - 1.29MB)

Glades Drugs, Pahokee, FL

Good Day Pharmacy, (see Professional Pharmacy Services, Inc.), Loveland, CO

Good Health Inc., (dba Premier Pharmacy Services), Baldwin Park, CA

483 Issued 11/29/2018 (PDF - 379KB)

Grandpa's Compounding Pharmacy, Inc. Placerville, CA

483 Issued 09/18/2015 (PDF - 322KB)
Warning Letter (05/02/2014)
483 Issued 09/10/2013 (PDF - 1.1MB)

Green Hills Health and Wellness Pharmacy, Inc. (dba Health and Wellness Compounding Pharmacy), Nashville, TN

FMD-145 Letter Issued 05/30/2017 (PDF - 54KB)
Referral Letter to the Tennessee Board of Pharmacy Issued 02/08/2017 (PDF - 403KB)
483 Issued 06/30/2016 (PDF - 516KB)
Warning Letter (06/04/2015)
483 Response Dated 11/11/2014 (PDF - 4.1MB)
483 Issued 10/22/2014 (PDF - 727KB)

Greenpark Compounding Pharmacy, (see Prescription Labs, Inc.), Houston, TX

Green Valley Drugs, (see FVS Holdings, Inc.), Henderson, NV

Guardian Pharmacy Services, Dallas, TX

FDA Press Release: Federal judge enters consent decree against Texas compounder, Guardian Pharmacy Services (03/12/2019)
483 Response Dated 06/08/2018 (PDF - 168KB)
Compounding Risk Alert: FDA’s Investigation into Guardian’s Compounded Triamcinolone-Moxifloxacin Drug Product (7/5/2018)
Amended 483 Issued 04/23/2018 (PDF - 3.1MB)
483 Issued 04/20/2018 (PDF - 2.7MB)
Warning Letter (11/03/2017)
Compounding Risk Alert: FDA Alerts Health Care Professionals of Adverse Events Associated with Guardian’s Compounded Triamcinolone and Moxifloxacin Product for Intravitreal Injection (7/28/2017)
Firm response to 483 dated 11/07/2016 (PDF - 3MB)
Corrected (No Redactions) 483 Issued 10/21/2016 (PDF - 361KB)

Hallandale Pharmacy, (see Pharmcore Inc.), Hallandale, FL

Hallettsville Pharmacy, LLC, Hallettsville, TX

FMD-145 Letter Issued 03/24/2021 (PDF - 185KB)
Referral Letter to the Texas State Board of Pharmacy Issued 03/24/2021 (PDF - 249KB)
Untitled Letter Issued 09/29/2020 (PDF - 182KB)
483 Issued 11/08/2018 (PDF - 468KB)

Hartley Medical Center Pharmacy, Inc., Long Beach, CA

Referral to the California State Board of Pharmacy Issued 09/26/2017 (PDF - 86KB)
483 Response dated (3/31/2017)
483 Issued 03/24/2017 (PDF - 203KB)
Warning Letter (04/21/2016)
Firm Press Release: Hartley Medical Issues Voluntary Recall of Prolotherapy with Phenol Due to Non-sterility Concerns (08/17/2015)
483 Issued 07/08/2015 (PDF - 548KB)

Hawaii Health Systems Corporation, (dba Kona Community Hospital Pharmacy), Kealakekua, HI

Warning Letter (02/01/2021)
483 Issued 12/13/2019 (PDF - 1.83MB)

Healix Infusion Therapy, Inc., Sugar Land, TX

State Referral Letter Issued 12/21/2017 (PDF - 75KB)
FMD-145 Letter Issued 12/21/2017 (PDF - 49KB)
483 Issued 09/14/2016 (PDF - 153KB)
483 Issued 05/16/2014 (PDF - 628KB)

Health and Wellness Compounding Pharmacy, (see Green Hills Health and Wellness Pharmacy, Inc.), Nashville, TN

Health Dimensions, Inc., Farmington Hills, MI

Referral Letter to the Michigan State Department of Licensing and Regulatory Affairs (LARA) Issued 05/21/2015 (PDF - 545KB)
483 Response Dated 08/29/2014 (PDF - 1.5MB)
483 Issued 08/08/2014 (PDF - 613KB)

Health Innovations Pharmacy, Inc., Southern Pines, NC

FMD-145 Letter Issued 04/21/2018 (PDF - 55KB)
Warning Letter (07/08/2016)
483 Issued 02/27/2015 (PDF - 805KB)

Health Solutions Pharmacy Center, Inc., (dba Professional Compounding Pharmacy), Corvallis, OR

Warning Letter (03/31/2020)
483 Issued 01/28/2019 (PDF - 1 MB)

The Healthy Choice Apothecary (see Jacobs Pills Inc.), Elmsford, NY

Healthy Choice Compounding LLC, Elmsford, NY 483

483 Issued 09/24/2020 (PDF - 254 KB)

Heartland Home Infusions, Inc. (dba HHI Infusion Services), Burr Ridge, IL

FMD-145 Issued 02/22/2018 (PDF - 70 KB)
State Referral Letter Issued 02/22/2018 (PDF - 206 KB)
483 Issued 07/27/2017 (PDF - 391 KB)

Heartland I.V. Care, Saint Paul, MN

State Referral Letter Issued 02/23/2018 (PDF - 81 KB)
FMD-145 Issued 02/23/2018 (PDF - 70 KB)
483 Issued 07/14/2017 (PDF - 162KB)

HHCS Pharmacy, Inc. (dba Freedom Pharmacy), Orlando, FL

Referral Letter to the Florida State Board of Pharmacy Issued 01/23/2017 (PDF - 466KB)
Warning Letter (05/14/2015)
483 Issued 07/28/2014 (PDF - 1.7MB)

Hieber's Pharmacy, Pittsburgh, PA

FMD-145 Letter Issued 05/01/2020 (PDF - 84KB)
483 Issued 07/17/2019 (PDF - 192KB)
Warning Letter (12/05/2017)
483 Issued 02/17/2017 (PDF - 1.2MB)
Warning Letter (09/29/2015)
483 Response Dated 10/17/2014 (PDF - 6.4MB)
483 Issued 09/18/2014 (PDF - 541KB)

Hiers Enterprises, LLC, (dba Northwest Compounding Pharmacy), Roseburg, OR

483 Issued 11/10/2021 (PDF - 1.1MB)
483 Issued 11/14/2018 (PDF - 1.57MB)

Highland Pharmacy (see In Your Atmosphere Holdings, LLC), Santa Fe, NM

Home Care Pharmacy of Palm Coast Inc., Palm Coast FL

Untitled Letter Issued 05/04/2020 (PDF - 485KB)
483 Issued 04/25/2018 (PDF - 354KB)
Warning Letter (08/31/2017)
483 Issued 05/25/2016 (PDF - 860KB)

HomeChoice Partners, Inc., (dba Bioscrip Infusion Services), Augusta, GA

483 Issued 08/09/2021 (PDF - 905KB)
Warning Letter (04/09/2020)
483 Issued 08/17/2018 (PDF - 437KB)

Home Infusions Solutions, Inc., Horsham, PA

Referral Letter to the Pennsylvania State Board of Pharmacy Issued 03/27/2014 (PDF - 144KB)
483 Issued 05/21/2013 (PDF – 573KB)

Home Intensive Care Pharmacy, Inc., San Antonio, TX

Referral Letter to the Texas State Board of Pharmacy Issued 05/05/2016 (PDF - 481KB)
Amended 483 Issued 05/05/2015 (PDF - 1.3MB)
483 Issued 05/05/2015 (PDF - 1.2MB)
Warning Letter Response Dated 02/09/2014
Warning Letter (01/22/2014)
483 Issued 03/01/2013 (PDF - 1.1MB)

HomeRx, LLC, (see WellRx, LLC), Wheaton, IL

Hopewell Pharmacy and Compounding Center, (see Drugs Are Us, Inc.), Hopewell, NJ

Hopkinton Drug, Inc., Hopkinton, MA

Untitled Letter Issued 09/16/2021 (PDF - 273KB)
483 Issued 11/10/2020 (PDF - 622KB)

Horizon Pharmaceuticals, Inc., Riviera Beach, FL

Warning Letter (12/23/2016)

Hospira Inc., A Pfizer Company, McPherson, KS

483 Issued 01/17/2020 (PDF - 2.58MB)
483 Issued 10/27/2017 (PDF - 1.8MB)

HRI Pharmacy, (see National Prescription Services), Warrenville, IL

Humco Holding Group, Inc., Texarkana, TX

Warning Letter (01/26/2017)

Hunter Holmes McGuire Veterans Admin Medical Center, Richmond, VA

483 Issue 07/19/2018 (PDF - 165KB)
483 Issued 10/25/2016 (PDF - 320KB)
483 Issued 03/11/2015 (PDF - 496KB)

HV Pharmacy Inc. (dba Hunt Valley PharmaLab), Cockeysville, MD

FMD-145 Letter Issued 08/23/2019 (PDF - 323KB)
Referral Letter to the Maryland State Board of Pharmacy Issued 08/23/2019 (PDF - 87KB)
483 Issued 08/17/2018 (PDF - 290KB)

Hybrid Pharma LLC, Deerfield Beach, FL

Warning Letter (06/07/2022)
483 Issued 09/03/2021 (PDF - 1.42MB)
Amended 483 Issued 06/24/2019 (PDF - 1.4MB)
Warning Letter (11/30/2018 )
483 Issued 07/28/2016 (PDF - 1.6MB)

Ideal Specialty Apothecary Inc., (dba Ideal Pharmacy), Union, NJ

483 Issued 11/18/2021 (PDF - 1.48MB)
Warning Letter (06/17/2019)
483 Issued 08/31/2017 (PDF - 553KB)

ImprimisRx CA Inc. (dba ImprimisRx), Irvine CA

Warning Letter (03/26/2019)
Compounding Risk Alert: A Case of Hemorrhagic Occlusive Retinal Vasculitis (HORV) Following Intraocular Injections of a Compounded Triamcinolone, Moxifloxacin, and Vancomycin Formulation (10/3/2017)
Compounding Risk Alert: FDA Investigates Two Serious Adverse Events Associated with ImprimisRx’s Compounded Curcumin Emulsion Product for Injection (8/4/2017)
483 Issued 03/31/2017 (PDF - 558KB)
Warning Letter (03/20/2017)

Imprimis NJOF, LLC, Ledgewood, NJ

483 Issued 01/29/2021 (PDF - 5.35MB)
Warning Letter (06/07/2019)
483 Issued 07/10/2017 (PDF - 1.6MB)

ImprimisRx NJ, Ledgewood, NJ

483 Issued 04/09/2019 (PDF - 305KB)
Untitled Letter (09/25/2018)
483 Issued 07/10/2017 (PDF - 190KB)

ImprimisRx Pharmacy, LLC, Folcroft, PA

Warning Letter (08/03/2017)
483 Issued 08/01/2016 (PDF - 1.7MB)

INCELL Corporation, LLC, San Antonio, TX

Warning Letter (12/28/2016)
483 Issued 09/01/2015 (PDF - 824KB)

Infupharma, LLC (dba President Pharmacy), Hollywood, FL

Closeout Letter issued 2/16/2016 (PDF - 404KB)
483 Issued 02/05/2015 (PDF - 685KB)
Warning Letter Close Out 06/26/2013
Warning Letter (07/30/2012)
483 Response Dated 10/10/2011 (PDF - 40KB)
483 Issued 09/27/2011 (PDF - 2.9MB)
Investigation Memo and Attachments, 08/16/2011 (PDF - 3.1MB)

InfuScience Inc., Eagan, MN

FMD-145 Letter Issued 07/01/2019 (PDF - 101KB)
Referral Letter to the Minnesota State Board of Pharmacy Issued 07/01/2019 (PDF - 127KB)
483 Issued 04/25/2018 (PDF - 761KB)

InfuScience a subsidiary of Bioscrip, Mount Pleasant, SC

Referral to the South Carolina State Board of Pharmacy Issued 09/13/2017 (PDF - 56KB)
483 Issued 05/15/2015 (PDF - 973KB)

InfuScience, Inc., (dba Bioscrip Infusion Services), Chantilly, VA

483 Issued 10/08/2021 (PDF - 1.17MB)
Warning Letter (12/21/2020)
483 Issued 07/30/2019 (PDF - 1MB)

Infusion Options, Inc., Brooklyn, NY

Warning Letter (08/26/2021)
Amended 483 Issued 07/08/2019 (PDF - 2.16MB)
483 Issued 06/25/2019 (PDF - 261KB)
483 Issued 06/01/2017 (PDF - 1.3MB)
Warning Letter (03/21/2016)
483 Issued 04/23/2014 (PDF - 2.3MB)

Infusion Partners, LLC, Canfield, OH

Referral Letter to the Ohio Board of Pharmacy Issued 03/28/2019 (PDF - 75KB)
Warning Letter (03/20/2019)
483 Issued 01/26/2018 (PDF - 678KB)

Infusion Partners (subsidiary of BioScrip), Sharpsburg, PA

483 Response Dated 02/10/2015 (PDF - 7.6MB)
483 Response Dated 01/09/2015 (PDF - 7.6MB)
Amended 483 Issued 12/10/2014 (PDF - 976KB)
483 Issued 12/05/2014

Infusion System of SW Florida Inc. (dba Myerlee Pharmacy), Fort Myers, FL

483 Issued 12/17/2019 (PDF - 690KB)
483 Issued 07/20/2017 (PDF - 1.36MB)
Warning Letter (02/03/2016)
483 Issued 12/22/2014 (PDF - 1.6MB)

Infusion Treatment Center, dba ITC Compounding, Castle Rock, CO

Referral Letter to the Colorado Board of Pharmacy Issued 12/23/2020 (PDF - 85 KB)
FMD-145 Letter Issued 12/01/2020 (PDF - 67KB)
Untitled Letter Issued 08/18/2020 (PDF - 158KB)
483 Issued 07/23/2019 (PDF - 1.6MB)

Innovative Compounding Pharmacy, Folsom, CA

FMD-145 Letter Issued 06/07/2018 (PDF - 45KB)
State Handoff Letter Issued 06/07/2018 (PDF - 48KB)
Warning Letter (06/20/2016)
483 Issued 04/17/2015 (PDF - 1MB)

Innovation Compounding, Inc. Kennesaw, GA

Closeout Letter Issued 12/30/2016 (PDF - 200KB)

Innovative Intrathecal Solutions, Inc. (dba Innovative Compounding Pharmacy), Murrieta, CA

483 Issued 10/26/2021 (PDF - 248KB)
483 Issued 02/20/2020 (PDF - 983KB)
Warning Letter (09/19/2018)
483 Issued 12/18/2017 (PDF - 502KB)

Innovative Medicine LLC, Long Island City, NY

Warning Letter (11/17/2020)

Innoveix Pharmaceuticals, Addison, TX

Warning Letter (01/26/2022)
483 Issued 05/27/2021 (PDF - 981KB)
Firm Recall Announcement: Innoveix Pharmaceuticals, Inc. Issues Voluntary Recall of all Sterile Compounded Drug Products Due to a Lack of Sterility Assurance (10/10/2019)
483 Issued 09/12/2019 (PDF - 1.18MB)

Insight Pharmacy, Havertown, PA

FMD-145 Letter Issued 10/03/2019 (PDF - 90KB)
Referral Letter to the Pennsylvania State Board of Pharmacy Issued 10/03/2019 (PDF - 90KB)

Intact Pharmaceuticals, LLC, New Milford, CT

483 Issued 10/12/2018 (PDF - 2.8MB)

IntegraDose Compounding Services, LLC, Minneapolis, MN

483 Issued 08/02/2021 (PDF - 1.12MB)
Warning Letter (05/06/2020)
483 Issued 09/19/2018 (PDF - 1.3MB)

Integrated Health Concepts Inc. (dba Conversio Health), San Luis Obispo, CA

483 Issued 07/23/2021 (PDF - 454KB)
Warning Letter (09/10/2020)

Intermountain Medical Center, Murray, UT

FMD-145 Letter Issued 10/25/2019 (PDF - 123KB)

Intrathecal Compounding Specialist, LLC, Scott, LA

483 Issued 08/19/2021 (PDF - 1.4MB)
Warning Letter (09/15/2020)
483 Issued 02/14/2019 (PDF - 417KB)
Firm response to 483 dated 12/08/2017 (PDF - 4.4MB)
Corrected 483 Issued 11/17/2017 (PDF - 499KB)

Inventive Infusion Solutions, LP, San Antonio, TX

Untitled Letter Issued 07/15/2021 (PDF - 377KB)
483 Issued 08/31/2018 (PDF - 720KB)

In Your Atmosphere Holdings LLC (dba Highland Pharmacy) Santa Fe, NM

Referral Letter to the New Mexico State Board of Pharmacy Issued 08/22/2017 (PDF - 78KB)
483 Issued 01/19/2017 (PDF - 1020KB)

Ionia Pharmacy, Tustin, CA

Warning Letter (12/22/2015)
483 Issued 03/06/2015 (PDF - 2MB)

Irmat Pharmacy (see Park Irmat Corp.) New York, NY

Isomeric Pharmacy Solutions, LLC, Salt Lake City, UT

FDA Press Release: Federal judge enters consent decree against outsourcing facility Isomeric Pharmacy Solutions (8/4/2017)
Firm Press Release: Isomeric Pharmacy Solutions Issues Voluntary Nationwide Recall of All Sterile Compounded Products (04/06/2017)
483 Issued 03/24/2017 (PDF - 3.3MB)
Warning Letter (12/12/2016)
483 Issued 06/29/2016 (PDF - 2.6MB)
483 Response Dated 09/17/2015 (PDF - 483KB)
483 Issued 08/28/2015 (PDF - 970KB)

Isorx, Corp., Richmond, CA

483 Issued 09/18/2019 (PDF - 376KB)

IV Solutions of Lubbock (see Maxor National Pharmacy Services Corporation), Lubbock, TX

Referral Letter to the Texas Board of Pharmacy Issued 03/18/2014 (PDF - 604KB)
483 Response Dated 04/02/2013 (PDF - 976KB)
483 Issued 03/20/2013 (PDF - 3.7MB)

I.V. Specialty, Ltd. Austin, TX

483 Issued 07/28/2017 (PDF - 594KB)
FDA Statement: FDA Alerts Health Care Professionals and Patients not to Use Human and Animal Sterile Drug Products Produced and Distributed by I.V. Specialty, Ltd., Austin, Texas (03/09/2016)
483 Issued 02/05/2016 (PDF - 1.5MB)
Warning Letter (04/21/2015)
483 Issued 07/22/2014 (PDF - 1019KB)

J & F International Inc. (dba Alexandria Medical Arts Pharmacy & Compounding Laboratory), Alexandria, VA

Warning Letter (04/09/2010)

Jack P. Herick Inc. (dba Glades Drugs), Pahokee, FL

Referral Letter to the Florida Board of Pharmacy Issued 04/21/2017 (PDF - 711KB)
Warning Letter (08/09/2016)
483 Issued 12/10/2015 (PDF - 606KB)
FDA Statement: FDA announces Glades Drugs’ nationwide voluntary recall of Compounded Multivitamins containing High Amounts of Vitamin D3 (Cholecalciferol) (11/25/2015)

Jacobs Pills Inc. (dba The Healthy Choice Apothecary), Elmsford, NY

483 Issued 02/28/2017 (PDF - 276KB)

Jajco Inc. (dba Anchor Drugs Pharmacy), South San Francisco, CA

Referral Letter to the California State Board of Pharmacy Issued 12/06/2019 (PDF - 115KB)
FMD-145 Letter Issued 12/06/2019 (PDF - 100KB)
Warning Letter (08/22/2017)
483 Issued 06/03/2016 (PDF - 1.5MB)

JCB Laboratories, LLC, Wichita, KS

483 Issued 09/14/2018 (PDF - 213MB)
483 Issued 12/03/2015 (PDF - 1MB)
Warning Letter (07/07/2014)
Firm Press Release: JCB Laboratories Issues Voluntary Recall of Six Drug Product Lots Due to Concerns of Sterility Assurance at Testing Vendor (08/26/2013)
483 Issued 02/27/2013 (PDF - 1.9MB)

JD & SN Inc. (dba Moses Lake Professional Pharmacy), Moses Lake, WA

FMD-145 Letter Issued 08/09/2018 (PDF - 46KB)
State Referral Letter Dated 08/09/2018 (PDF - 60KB)
483 Issued 07/12/2017 (PDF - 522KB)
Warning Letter (10/14/2016)
Firm Press Release: Moses Lake Professional Pharmacy Issues Voluntary Recall of Unexpired Sterile Human and Veterinary Compounded Drugs Due to Lack of Sterility Assurance (07/24/2015)
483 Issued 07/21/2015 (PDF - 2.6MB)

Jeffreys Drug Store, Canonsburg, PA

Warning Letter CloseOut (08/16/2018)
FMD-145 Letter Issued 08/16/2018 (PDF - 62KB)
State Referral Letter Issued 08/16/2018 (PDF - 70KB)
483 Issued 08/04/2017 (PDF - 549KB)
Warning Letter (08/25/2016)
483 Issued 02/09/2016 (PDF - 579KB)

Joe Wise Pharmacy, Inc., (dba Wise Pharmacy), Littleton, CO.

Warning Letter (04/15/2021)
483 Issued 06/21/2019 (PDF - 542KB)
483 Issued 05/23/2017 (PDF - 253KB)

John Hollis Pharmacy, (see John W. Hollis, Inc.), Nashville, TN

John W. Hollis, Inc. (dba John Hollis Pharmacy), Nashville, TN

Warning Letter Response Dated 09/18/2014
Warning Letter (09/04/2014)
483 Issued 03/21/2014 (PDF - 1.3MB)

John L. McClellan Memorial Veterans Hospital, Little Rock, AR

483 Issued 01/23/2020 (PDF - 1.72MB)

John's Pharmacy, Inc., (dba The Sullivan Pharmacy), Sullivan, IL

FMD-145 Letter Issued 05/26/2020 (PDF - 118KB)
Untitled Letter Issued 12/09/2019 (PDF - 648KB)
483 Issued 02/22/2019 (PDF - 384KB)

John’s Pharmacy LLLP, Cape Girardeau, MO

Referral Letter to the Missouri State Board of Pharmacy Issued 01/10/2017 (PDF - 55KB)
FMD-145 Letter Issued 01/10/2017 (PDF - 215KB)

Johnson Compounding and Wellness, (see Merissa Corp.), Waltham, MA

Johnson Memorial Cancer Center, Enfield, CT

483 Issued 10/21/2021 (PDF - 770KB)
Warning Letter (10/28/2015)
483 Issued 08/05/2014 (PDF - 916KB)

Jones Drug Company, Inc., (dba Reed's Compounding Pharmacy), Tucson, AZ

Amended 483 Issued 09/29/2015 (PDF - 2.4MB)
483 Issued 09/29/2015 (PDF - 2.8MB)
Warning Letter (01/07/2008)

Jubilant DraxImage Radiopharmacies, Inc., (dba Triad Isotopes, Inc.), Kansas City, MO

Untitled Letter Issued 05/03/2018 (PDF - 87KB)
483 Issued 07/03/2017 (PDF - 217KB)
Referral Letter to the Missouri State Board of Pharmacy Issued 03/10/2016 (PDF - 225KB)
Warning Letter (03/10/2016)
Amended 483 Issued 01/09/2015
483 Issued 01/09/2015

Jubilant HollisterStier, LLC, Spokane, WA

Jungle Jim's Pharmacy, Fairfield, OH

Referral Letter to the Ohio State Board of Pharmacy Issued 08/11/2015 (PDF - 113KB)
483 Issued 01/26/2015 (PDF - 500KB)

J.W. Platt, RPh LLC. (dba The Wellness Pharmacy), Winchester, VA.

Kalman Health & Wellness, Inc. (dba Essential Wellness Pharma), Peoria, IL

Referral Letter to the Illinois State Board of Pharmacy Issued 09/11/2019 (PDF - 118KB)
FMD-145 Letter Issued 09/11/2019 (PDF - 84KB)
483 Issued 06/27/2018 (PDF - 201KB)
Warning Letter (07/22/2016)
483 issued 07/21/2015 (PDF 1.6MB)

Kelley-Ross Compounding Pharmacy, Seattle, WA

483 Issued 09/23/2020 (PDF - 754KB)
Warning Letter (07/30/2018)
483 Issued 08/02/2017 (PDF - 989KB)

Key Compounding Pharmacy (see Puget Sound Drug Corporation), Federal Way, WA

Keystone Pharmacy, Grand Rapids, MI

FMD-145 Issued 06/14/2018 (PDF - 171KB)
State Referral Letter Issued 06/14/2018 (PDF - 174KB)
483 Issued 11/03/2017 (PDF - 442KB)

Keystone Rx LLC, Bensalem, PA

FMD-145 Letter Issued 03/25/2020 (PDF - 111KB)
483 Issued 07/12/2019 (PDF - 310KB)

Kings Park Slope, Inc., Brooklyn, NY

Referral Letter to the New York State Board of Pharmacy Issued 11/15/2019 (PDF - 120KB)
FMD-145 Issued 11/15/2019 (PDF - 111KB)
Warning Letter Closeout (11/15/2019)
483 Issued 09/14/2018 (PDF - 593KB)
483 Issued 04/22/2016 (PDF - 1.4MB)
Warning Letter (03/27/2015)
483 Issued 03/14/2014 (PDF - 3.2MB)

Kohana Pharmacy and Center for Regenerative Medicine Inc., San Luis Obispo, CA

FMD-145 Letter Issued 11/22/2019 (PDF - 69KB)
Referral Letter to the California State Board of Pharmacy Issued 11/22/2019 (PDF - 103KB)
483 Issued 04/17/2019 (PDF - 406KB)

Kohll's Compounding, Omaha, NE

FMD-145 Letter Issued 07/11/2019 (PDF - 112KB)
Referral Letter to the Nebraska State Board of Pharmacy Issued 07/11/2019 (PDF - 264KB)

Kona Community Hospital Pharmacy, (see Hawaii Health Systems Corporation), Kealakekua, HI

KRS Global Biotechnology, Inc. Boca Raton, FL

Firm Recall Announcement: KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of Assurance of Sterility (09/12/2019)
Amended 483 Issued 08/20/2019 (PDF - 2.51MB)
483 Issued 10/23/2017 (PDF - 705KB)
483 Issued 08/31/2016 (PDF - 2.2MB)
Warning Letter (07/06/2015)
483 Issued 03/17/2014 (PDF – 735KB)

Ladd Family Pharmacy LLC, Boise, ID

483 Issued 07/30/2019 (PDF - 321KB)
Warning Letter (09/26/2017)
483 Issued 09/23/2016 (PDF - 612KB)

Lato Drug Company, Inc. (dba Post Haste Pharmacy), Hollywood, FL

FMD-145 Letter Issued 10/26/2017 (PDF - 67KB)
483 Issued 02/20/2015 (PDF - 712KB)

La Vita Compounding Pharmacy, LLC, San Diego, CA

483 Issued 03/11/2020 (PDF - 868KB)
Warning Letter (02/28/2019)
483 Issued 06/08/2018 (PDF - 870KB)

Lee and Company (dba Lee Pharmacy, Inc.), Fort Smith, AR

Warning Letter Response Dated 06/26/2014
Warning Letter (06/06/2014)
483 Issued 02/21/2013 (PDF - 2.6MB)

Lee Pharmacy, Inc. (see Lee and Company), Fort Smith, AR

LeeSar, Inc., Fort Myers, FL

483 Issued 10/29/2021 (PDF - 976KB)
Warning Letter (02/18/2020)
483 Issued 07/12/2017 (PDF - 991B)
483 Issued 08/08/2014 (PDF – 541KB)

Lee Silsby Compounding Pharmacy, (see Gipsco Investment Corp.), Cleveland Heights, OH

Leiter's Cambrian Park Drugs, Inc., (dba Leiter's Compounding Pharmacy), 1700 Park Avenue, San Jose, CA

Warning Letter Response Dated 04/21/2015
Warning Letter (04/14/2015)
483 Response Dated 03/26/2014 (PDF - 3.6MB)
483 Issued 03/06/2014 (PDF - 1.3MB)
483 Response Dated 11/25/2013 (PDF - 5MB)
483 Issued 11/05/2013 (PDF - 3.8MB)
Firm Press Release: Leiter's Compounding Pharmacy Issues Voluntary Nationwide Recall of Three Product Lots Due to Lack of Assurance of Sterility Concerns Related to its Independent Testing Vendor (09/10/2013)

Leiter's Compounding, 17 Great Oaks Blvd., San Jose, CA

483 Issued 12/19/2018 (PDF - 335KB)
FMD-145 Letter Issued 05/29/2018 (PDF - 41KB)
483 Issued 06/15/2017 (PDF - 715KB)
Warning Letter (02/29/2016)
Amended 483 Issued 10/08/2014
483 Issued 10/07/2014

Leiter's Compounding Pharmacy, (see Leiter's Cambrian Park Drugs, Inc.), San Jose, CA

Leiter's Health, (see Denver Solutions, LLC), Englewood, CO

Liberty Drug and Surgical, Chatham, NJ

FMD-145 Letter Issued 02/25/2019 (PDF - 108KB)
Untitled Letter Issued 04/12/2018 (PDF - 79KB)
Warning Letter (03/14/2016)
483 Issued 05/26/2015 (PDF - 926KB)

Life Science Pharmacy, Inc., Harriman, NY

Untitled Letter Issued 12/09/2020 (PDF - 211KB)
483 Issued 11/20/2019 (PDF - 663KB)

Lifetime Value Pharmacy III Inc., Santa Ana, CA

Untitled Letter Issued 09/22/2020 (PDF - 130KB)
483 Issued 02/21/2019 (PDF - 1.9MB)

Lincare, Inc. (dba United Medical Home Infusion), Little Rock, AR

State Referral Letter Issued 03/05/2018 (PDF - 84KB)
483 Issued 08/22/2017 (PDF - 218KB)
Warning Letter (04/25/2016)
Amended 483 Issued 06/12/2015 (PDF - 1.5MB)
483 Issued 06/12/2015 (PDF - 1.3MB)

Lloyd Central Compounding Pharmacy, (see Portland Compounding Pharmacy, LLC), Portland, OR

Loop Pharmacy & Home Medical, Saint Albans, WV

483 Issued 09/25/2018 (PDF - 331KB)
Warning Letter (09/20/2017)
483 Issued 12/16/2016 (PDF - 1.1MB)

Louisville Pharmacy (see Spoonamore Drug Co., Inc.), Louisville, KY

Lowlite Investments, Inc. (dba Olympia Pharmacy), Orlando, FL

Warning Letter (02/18/2014)
Firm Press Release: Lowlite Investments, Inc. d/b/a Olympia Pharmacy Announces a Voluntary Multi-State Recall of All Sterile Compounded Products Compounded Between December 17, 2012, and March 27, 2013, Due to Concerns About Sterility Assurance (05/29/2013)
483 Issued 03/21/2013 (PDF - 717KB)

Lowlyn Pharmacies, Inc. (dba Red Cross Drug), Blanchard, OK

Referral Letter to Oklahoma State Board of Pharmacy Issued 02/25/2014 (PDF - 2.4MB)
483 Issued 03/08/2013 (PDF - 732KB)

Lynnfield Drug, Inc. (dba Freedom Fertility Pharmacy), Byfield, MA

FMD-145 Letter Issued 09/26/2018 (PDF - 68KB)
State Referral Letter Issued 09/24/2018 (PDF - 75KB)
483 Issued 02/27/2018 (PDF - 421KB)

M Drug, LLC, (dba Northern Light Pharmacy), Bangor, ME

FMD-145 Letter Issued 04/01/2020 (PDF - 164KB)
Amended 483 Issued 08/20/2019 (PDF - 819KB)

Maag Prescription Center LLC, Pocatello, ID

483 Issued 09/28/2018 (PDF - 745KB)

Madison Drugs (see Service First Pharmacies, Inc.), Huntsville, AL

Magellan Rx Pharmacy LLC, Astoria, NY

FMD-145 Letter Issued 06/06/2019 (PDF - 92KB)
Referral Letter to the New York State Board of Pharmacy Issued 06/06/2019 (PDF - 95KB)
Warning Letter (09/11/2017)
483 Issued 12/22/2016 (PDF - 976KB)

Maimonides Medical Center-Pharmacy, Brooklyn, NY

483 Issued 07/29/2019 (PDF - 2.1MB)

Main Street Family Pharmacy, Newbern, TN

FDA Press Release: FDA resolves criminal and civil actions against Main Street Family Pharmacy (12/04/2014)
483 Issued 06/11/2013 (PDF - 873KB)
FDA Statement: Update on Main Street Family Pharmacy Products: Samples of injectable methylprednisolone acetate test positive for microbial contamination (06/06/2013; Updated 06/12/2014; Updated 06/13/2014)
Firm Press Release: Main Street Family Pharmacy, LLC Issues Voluntary Nationwide Recall of All Sterile Compounded Products (05/28/2013)
FDA Press Release: FDA alerts health care providers of adverse reactions associated with steroid injections from Main Street Family Pharmacy in Tennessee (05/24/2013)

Maitland Labs of Central Florida, Orlando, FL

Warning Letter (08/06/2021)
483 Issued 02/28/2020 (PDF - 1MB)
483 Issued 06/17/2019 (PDF - 1.06MB)

Malley's Compounding Pharmacy, (see Columbia River Pharmacy, LLC), Richland, WA

Malanda, Inc., (dba Mandell's Clinical Pharmacy), Somerset, NJ

Warning Letter (06/09/2020)
483 Issued 07/25/2019 (PDF - 746KB)

Maplerose Enterprises, LLC (dba Pencol Pharmacy), Denver, CO

Untitled Letter Issued 08/18/2020 (PDF - 102KB)
483 Issued 02/26/2019 (PDF - 1.9MB)
Warning Letter (08/02/2017)
483 Response Dated 09/12/2016 (PDF - 537KB)
483 Issued (08/22/2016)

Mark Drugs Pharmacy, (see Snyder Mark Drugs Roselle, Inc.), Roselle, IL

Marlborough Hospital, Marlborough, MA

Martin Avenue Pharmacy, Inc., Naperville, IL

Warning Letter (03/18/2015)
Firm Press Release: Martin Avenue Pharmacy, Inc., Issues a Voluntary Multi-State Recall of All Compounded Sterile Preparations Due to a Lack of Assurance of Sterility (08/27/2014)
483 Issued 07/21/2014 (PDF - 1.8MB)

Maryland Specialty and Compounding, LLC dba Professional Arts Pharmacy, Baltimore, MD

FMD-145 Letter Issued 5/29/2020 (PDF-186KB)
State Referral Letter Issued 5/29/2020 (PDF-203KB)
FMD-145 Letter Issued 03/11/2019 (PDF - 130KB)

MasterPharm LLC. Richmond Hill, NY

483 Issued 6/15/2020 (PDF-8MB)
Referral to the New York State Education Department, Office of the Professions, Pharmacy Issued 07/07/2017 (PDF - 66 KB)
483 Issued 01/30/2017 (PDF - 220KB)
Warning Letter (01/08/2016)
483 Issued 05/06/2015 (PDF - 711 KB)

Matthew 7:25 Inc, (dba Thrive Pharmacy), Jacksonville, FL

Warning Letter (07/22/2021)

Maxor National Pharmacy Services Corporation, (dba IV Solutions of Lubbock), Lubbock TX

Mayo Clinic Pharmacy, Rochester, MN

FMD-145 Letter Issued 04/10/2019 (PDF - 104KB)
Referral Letter to the Minnesota State Board of Pharmacy Issued 04/10/2019 (PDF - 123KB)
483 Issued 08/15/2018 (PDF - 2.41MB)

McAlister Drug Corporation, (dba Conrad-Marr Drug), Yukon, OK

Referral Letter to the Oklahoma State Board of Pharmacy Issued 10/2/2020 (PDF - 199KB)
Untitled Letter Issued 08/21/2020 (PDF - 222KB)
483 Issued 10/03/2019 (PDF - 1.01MB)

McGuff Compounding Pharmacy Services, Inc., Santa Ana, CA

FMD-145 Letter Issued 05/29/2020 (PDF - 60KB)
483 Issued 11/22/2019 (PDF - 978KB)
FMD-145 Letter Issued 08/17/2018 (PDF - 45KB)
State Handoff Letter Dated 08/17/2018 (PDF - 48KB)
Warning Letter (11/13/2015)
483 Issued 12/31/2014

MD Custom Rx, (see Brookfield Prescription Center), Brookfield, WI

Med 4 Home Inc., (dba Med 4 Home Pharmacy), Kansas City, MO

Referral Letter to the Missouri Board of Pharmacy Issued 02/18/2015 (PDF - 306KB)

Medaus, Inc., Birmingham, AL

Warning Letter (03/08/2018)
FDA Press Release: FDA reminds health care professionals not to use drug products intended to be sterile from Medaus (05/05/2016)
FDA Requested Recall Letter Issued 05/03/2016 (PDF - 408KB)
FDA Statement: FDA alerts health care professionals and patients not to use sterile drug products from Medaus Pharmacy, Birmingham, Alabama (04/01/2016)
483 Issued 03/11/2016 (PDF - 872KB)
Warning Letter (01/15/2014)
Firm Press Release: Medaus Pharmacy Initiates a Nationwide Recall of Certain Pharmacy Products due to Questions Surrounding an Independent Third Party’s Sterility Testing (09/04/2013)
483 Issued 03/22/2013 (PDF - 712KB)

Medcraft LLC, Mounds, OK

FMD-145 Letter Issued 01/30/2019 (PDF - 77KB)
483 Issued 07/27/2018 (PDF - 251KB)

Medi-Fare Drug & Home Health Center, Inc., Blacksburg, SC

Untitled Letter 03/18/2019 (PDF - 1.58MB)
483 Issued 09/12/2014 (PDF - 371KB)
483 Issued 06/21/2013 (PDF - 2.4 MB)
Warning Letter (03/07/2013)
483 Issued 01/18/2013 (PDF - 3.5MB)

Medi-Home Infusion Pharmacy, Irmo, SC

Referral Letter to the South Carolina State Board of Pharmacy Issued 05/21/2015 (PDF - 820KB)
483 Issued 09/17/2014 (PDF - 643KB)

Medical Center Pharmacy, Inc., Cleveland, TN

483 Issued 04/09/2020 (PDF - 2.2MB)
Warning Letter (07/21/2017)
483 Issued 10/13/2015 (PDF - 1.2MB)

Medicine Store Pharmacy, Inc., (dba RXPress Pharmacy), Fort Worth, TX

Referral to the Texas State Board of Pharmacy Issued 07/28/2017 (PDF - 55KB)

MedisourceRx, Los Alamitos, CA

483 Issued 10/22/2020 (PDF - 1.15MB)
Amended 483 Issued 09/27/2018 (PDF - 1.9MB)
483 Issued 09/27/2018 (PDF - 2MB)

Medistat RX, LLC, (see Newman Inc.), Foley, AL

Meditech Laboratories, Inc., Las Vegas, NV

State Referral Letter to the Nevada State Board of Pharmacy issued 12/06/2017 (PDF - 51KB)
483 Issued 05/11/2017 (PDF - 58KB)
Warning Letter (10/19/2016)
483 Issued 03/18/2016 (PDF - 2MB)

Medlife Pharmacy and Compounding, Inc., Irvine, CA

Warning Letter (04/24/2020)
483 Issued 04/18/2018 (PDF - 845KB)

Medoz Pharmacy of Polk, Inc., Davenport, FL

483 Issued 08/27/2021 (PDF - 244KB)
Warning Letter (09/25/2020)
483 Issued 08/09/2019 (PDF - 1.21MB)

MedPark Pharmacy, Annapolis, MD

Warning Letter (03/05/2018)
483 Issued 3/10/2017 (PDF - 550KB)
483 Issued 05/23/2016 (PDF - 443KB)

MedPrep Consulting, Tinton Falls, NJ

DOJ Press Release: Senior Executives of Medical Drug Re-Packager Plead Guilty to Defrauding Healthcare Providers (July 14, 2017)
FDA Press Release: Federal Judge Enters Consent Decree with Med Prep Consulting (06/28/2013)
483 Issued 04/03/2013 (PDF - 6.9MB)
Firm Press Release: Medprep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination (03/20/2013)
FDA Press Release: FDA Alerts Health Care Providers of Recall of All Sterile Drug Products by Med Prep Consulting in New Jersey (03/18/2013)
Firm Press Release: MedPrep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of All Compounded Products Due To Potential Mold Contamination (03/17/2013)
Firm Press Release: MedPrep Consulting Inc. Announces Voluntary Nationwide Recall Of All Lots Of Magnesium Sulfate 2gm In Dextrose 5% In Water, 50ml For Injection Due To Mold Contamination (03/16/2013)
Warning Letter (07/09/2010)

Meds IV, (see Advanced Specialty Pharmacy), Bessemer, AL

MedScript Compounding Pharmacy, (see D&D Pharma, LLC), Noblesville, IN

Med Shop Total Care, Inc., Longview, TX

Warning Letter (03/18/2022)
483 Issued 07/27/2021 (PDF - 9.94KB)
483 Issued 11/01/2018 (PDF - 2.44MB)

Merissa Corp., (dba Johnson Compounding and Wellness), Waltham, MA

Referral Letter to Massachusetts Board of Registration in Pharmacy Issued 01/20/2016 (PDF - 47KB)
483 Issued 05/28/2015 (PDF - 1MB)

Meta Pharmacy Services, (see Barclay Luke & Pillai Specialty Pharmacy PLLC), Las Vegas, NV

Metro Drugs 3rd Avenue Corp, New York, NY

Untitled Letter Issued 01/08/2021 (PDF - 658KB)
483 Issued 04/05/2019 (PDF - 3.92MB)

MFP Limited (dba Prescription Lab Compounding Pharmacy), Tucson, AZ

Referral Letter to the Arizona State Board of Pharmacy Issued 05/23/2017 (PDF - 59KB)
Warning Letter (11/16/2016)
483 Issued 09/10/2015 (PDF - 340KB)

Michigan Medicine, Ann Arbor, MI

FMD-145 Letter Issued 06/13/2019 (PDF - 88KB)
Referral Letter to the Michigan State Board of Pharmacy Issued 06/13/2019 (PDF - 123KB)
483 Issued 12/14/2018 (PDF - 3.78MB)

Miller’s Health Mart Pharmacy, (see D&S Enterprises, LLC), Vero Beach, FL

Millers of Wyckoff, Inc., Wyckoff, NJ

Untitled Letter Issued 12/01/2021 (PDF - 339KB)
483 Issued 10/09/2020 (PDF - 620KB)
Warning Letter CloseOut (02/26/2019)
FMD-145 Letter Issued 02/26/2019
State Referral Letter Issued 02/26/2019 (PDF - 218KB)
483 Issued 05/18/2017 (PDF - 413KB)
Warning Letter (06/07/2016)
483 Issued 07/16/2015 (PDF - 1.2MB)

Mills Pharmacy at McCalla, McCalla, AL

FMD-145 Letter Issued 6/4/2020

Montana Compounding Pharmacy dba Montana Compounding Pharmacy and Wellness Center, Missoula, MT

483 Issued 09/22/2021(PDF -1.04MB)
Warning Letter (05/09/2018)
483 Issued 09/20/2016 (PDF - 518KB)
Warning Letter (12/11/2015)
483 Issued 05/08/2015 (PDF - 2.5MB)

Mooney's Pharmacy Inc., Johnson City, TN

FMD-145 Letter Issued 05/09/2017 (PDF - 67KB)
Referral Letter to the Tennessee Board of Pharmacy Issued 04/05/2017 (PDF - 430KB)
483 Response Dated 09/10/2016 (PDF - 721KB)
483 Issued 09/02/2016 (PDF - 289KB)

Moore's Compounding Pharmacy, Corpus Christi, TX

FMD-145 Issued 08/02/2018 (PDF - 45KB)
483 Issued 01/13/2017 (PDF - 298KB)

Moore's Pharmacy Inc., Sinton, TX

Warning Letter (01/16/2018)
483 Issued 09/01/2016 (PDF - 1.7MB)

Morton Drug Company (dba Morton LTC), Neenah, WI

FMD-145 Letter Issued 06/13/2019 (PDF - 109KB)
Referral Letter to the Wisconsin State Board of Pharmacy Issued 06/13/2019 (PDF - 710KB)
483 Issued 08/31/2018 (PDF - 221KB)
Warning Letter (10/26/2016)
483 Issued 12/22/2015 (PDF - 754KB)

Moses Lake Professional Pharmacy, (see JD & SN Inc.), Moses Lake, WA

MPRX Inc., dba Medical Park Pharmacy, Dallas, TX

483 Issued 11/22/2019 (PDF - 369KB)

Murray Avenue Apothecary, Pittsburgh, PA

Warning Letter (01/07/2008)

Myerlee Pharmacy, (see Infusion System of SW Florida), Fort Myers, FL

Mytilini Enterprises LLC, (see Bedford Pharmacy Inc.), Bedford, NH

Nanobots Healthcare, LLC, (dba Assurance Infusion), Houston, TX

Warning Letter (06/12/2020)
483 Issued 12/03/2019 (PDF - 645KB)

National Central Pharmacy, (see Abilene Nuclear LLC), Abilene, TX

National Prescription Services Inc., (dba HRI Pharmacy), Warrenville, IL

FMD-145 Letter Issued 04/04/2017 (PDF - 213KB)
483 Issued 04/04/2017
483 Issued 11/24/2014

Nature's Pharmacy and Compounding Center, Asheville, NC

Warning Letter (05/09/2014)
483 Issued 11/22/2013 (PDF - 1MB)
Firm Press Release: Nature's Pharmacy and Compounding Center Issues Voluntary Recall of All Sterile Compounded Products Distributed Within North Carolina Due to Lack of Sterility Assurance (11/13/2013)

Nebraska Methodist Hospital, Omaha, NE

Referral Letter to the Nebraska State Board of Pharmacy Issued 05/09/2016 (PDF - 336KB)
483 Issued 12/18/2015 (PDF - 632KB)
483 Issued 07/14/2014 (PDF - 772KB)

Nemours Alfred I. duPont Hospital for Children, Wilmington, DE

Referral Letter to the Delaware State Board of Pharmacy Issued 04/28/2017 (PDF - 910KB)

Nephron Pharmaceuticals Corporation, West Columbia, SC

483 Issued 04/20/2022 (PDF - 3MB)
483 Issued 11/15/2019 (PDF - 1.5MB)
483 Issued 04/20/2018 (PDF - 321KB)
483 Issued 04/21/2017 (PDF - 581KB)

New England Compounding Center, Framingham, MA

Unlicensed Pharmacy Technician Sentenced for Working at New England Compounding Center (7/17/2019)
Owner and Four Former Employees of New England Compounding Center Convicted Following Trial (12/13/2018)
Unlicensed Pharmacy Technician Pleads Guilty to Working at New England Compounding Center (8/17/2018)
Compounding Pharmacy Owner Sentenced to Five Years in Prison for $10.5 Million Health Care Fraud (3//27/2018)
DOJ Press Release: New England Compounding Center Pharmacist Sentenced for Role in Nationwide Fungal Meningitis Outbreak (January 31, 2018)
DOJ Press Release: Supervisory Pharmacist of New England Compounding Center Convicted of Racketeering Leading to Nationwide Fungal Meningitis Outbreak (October 25, 2017)
DOJ Press Release: Owner of New England Compounding Center Sentenced for Racketeering Leading to Nationwide Fungal Meningitis Outbreak (June 26, 2017)
DOJ Press Release: Owner of New England Compounding Center Convicted of Racketeering Leading to Nationwide Fungal Meningitis Outbreak (March 22, 2017)
DOJ Press Release: Majority Owner of NECC and Husband Plead Guilty to Illegal Cash Withdrawals Following Outbreak (July 29, 2016)
DOJ Press Release: $18 Million Seized from Owners of New England Compounding Center (1/6/2015)
DOJ Press Release: Luxury Car and Boat Seized From Former Head Pharmacist of New England Compounding Center (06/10/2015)
DOJ Press Release: 14 Indicted in Connection with New England Compounding Center and Nationwide Fungal Meningitis Outbreak (12/17/2014)
DOJ Press Release: New England Compounding Center Supervising Pharmacist Arrested at Logan International Airport (09/04/2014)
Multistate outbreak of fungal meningitis and other infections (12/12/2012)
Drug Safety Podcast: Investigation into New England Compounding Center (11/13/2012)
FDA Press release: FDA Reports Conditions Observed at New England Compounding Center Facility (10/26/2012)
483 Issued 10/26/2012 (PDF - 1.72MB)
Firm Press Release: New England Compounding Center Issues Voluntary Nationwide Recall of All Products (10/06/2012)

New England Home Therapies, Inc., Southborough, MA

Referral to the Massachusetts State Board of Registration in Pharmacy Issued 09/26/2017 (PDF - 93KB)
483 Issued 01/27/2016 (PDF - 1.6MB)
483 Issued 10/08/2014 (PDF - 385KB)

New England Life Care, Inc., Portland, ME

483 issued 03/02/2018 (PDF - 931KB)

New England Life Care, Inc., (dba Advanced Compounding Solutions), Woburn, MA

Untitled Letter Issued 8/21/2019 (PDF-182KB)
483 Issued 02/08/2018 (PDF - 907KB)
483 Response Dated 09/08/2017 (PDF - 234KB)
483 Issued 08/22/2017 (PDF - 1.19MB)

New Era Pharmacy, LLC, (see Pharmacy Acquisition Co., LLC), Portland, OR

Newman Inc., (dba Medistat RX, LLC), Foley, AL

FDA Press Release: Federal Judge Enters Consent Decree Against Alabama Compounder Medistat (7/6/2017)
483 Issued 09/23/2015 (PDF - 1.7MB)
FDA Statement: FDA Announces Medistat RX's Nationwide Voluntary Recall of Sterile Drug Products (09/09/2015)
483 Issued 09/18/2014 (PDF - 798KB)
Warning Letter (06/24/2008)

New Vitalis Pharmacy, LLC, (dba New Vitalis Pharmacy), Louisville, KY

Warning Letter (05/18/2022)
483 Issued 08/27/2021 (PDF - 894KB)
483 Issued 09/07/2018 (PDF - 531KB)

Nora Apothecary and Alternative Therapies, Inc., (dba Rx Compounding Inc.), Indianapolis, IN

Amended 483 Issued 09/16/2016 (PDF - 652KB)
483 Response Dated 09/06/2016 (PDF - 1.2MB)
483 Issued 08/19/2016 (PDF - 626KB)
483 Issued 08/21/2014 (PDF - 422KB)
Warning Letter (02/14/2014)
Firm Press Release: Nora Apothecary & Alternative Therapies Announces a Voluntary Multi-State Recall of All Sterile Compounded Products Due to a Lack of Sterility Assurance (04/22/2013)
483 Issued 03/21/2013 (PDF - 309KB)

Northern Light Pharmacy, (see M Drug, LLC), Bangor, ME

Northern New England Compounding Pharmacy, LLC, (dba Eastern States Compounding Pharmacy), Littleton, NH

Referral Letter to New Hampshire State Borad of Pharmacy Issued 04/29/2015 (PDF - 117KB)
483 Response Dated 10/08/2014 (PDF - 678KB)
483 Issued 09/30/2014 (PDF - 455KB)

North Laurel Discount Drug, Inc., (dba Quinn Pharmacy), Laurel, MS

FMD-145 Letter Issued 10/15/2020 (PDF - 252KB)
Untitled Letter Issued 06/11/2020 (PDF - 467KB)
483 Issued 08/16/2018 (PDF - 236KB)

Northwest Compounding Pharmacy, (see Hiers Enterprises, LLC), Roseburg, OR

Nubratori Inc. dba Nubratori Rx, Torrance, CA

483 Issued 09/26/2019 (PDF - 637KB)
FMD-145 Letter Issued 05/15/2019 (PDF - 65KB)

Nutrishare Inc., Louisville, KY

Referral Letter to the Kentucky State Board of Pharmacy Issued 03/04/2020 (PDF - 594 KB)
FMD-145 Letter Issued 03/04/2020 (PDF - 104KB)
483 Issued 07/26/2018 (PDF - 828KB)
Warning Letter (01/16/2018)
483 Issued 05/26/2017 (PDF - 75KB)

NuVision Pharmacy, (see Downing Labs, LLC), Dallas, TX

Oakdell Pharmacy, Inc., San Antonio, TX

State Referral Letter Issued 12/21/2017 (PDF - 80KB)
FMD-145 Letter Issued 12/21/2017 (PDF - 66KB)
483 Issued 03/29/2017 (PDF - 422KB)
Warning Letter Response Dated 06/18/2014
Warning Letter (05/27/2014)
483 Issued 03/01/2013 (PDF - 1.1MB)

O'Brien Pharmacy, Mission, KS

Referral to the Kansas State Board of Pharmacy Issued 06/28/2017 (PDF - 100KB)

Olympia Pharmacy, (see Lowlite Investments, Inc.), Orlando, FL

Olympia Pharmacy, (see OPS International, Inc.), Orlando, FL

OncoMed (Onco 360), (see Sina LLC), Great Neck, NY

One Way Drug, LLC, (dba Partell Specialty Pharmacy), Las Vegas, NV

FMD-145 Letter Issued 6/16/2020 (PDF-61KB)
483 Issued 11/25/2019 (PDF - 351KB)
Warning Letter (03/13/2019)
483 Issued 03/08/2018 (PDF - 1.4MB)
483 Issued 07/19/2017 (PDF - 427KB)
Warning Letter (07/22/2015)
483 Issued 05/30/2014 (PDF - 1.3MB)

OPS International, Inc., (dba Olympia Pharmacy), Orlando, FL

483 Issued 04/13/2018 (PDF - 1.6MB)
Warning Letter (02/04/2016)
483 Issued 12/04/2014 (PDF - 1.3MB)

Option Care, Wood Dale, IL

FMD-145 Letter Issued 07/01/2020 (PDF - 121KB)
FMD-145 Letter Issued 07/01/2020 (PDF - 96KB)
Referral Letter to the Illinois State Board of Pharmacy Issued 07/01/2020 (PDF - 110KB)
483 Issued 02/08/2018 (PDF - 534KB)
Warning Letter (09/28/2017)
483 Issued 09/21/2016 (PDF - 432KB)

Option Care, Houston, TX

FMD-145 Letter Issued 04/26/2018 (PDF - 54KB)
State Referral Letter Issued 04/26/2018 (PDF - 62KB)
483 Issued 08/02/2017 (PDF - 193KB)

Option Care Enterprises, Inc., (dba Option Care), Little Rock, AR

State Referral Letter Issued 12/20/2019 (PDF - 82KB)
FMD-145 Letter Issued 12/20/2019 (PDF - 57KB)
483 Issued 03/12/2019 (PDF - 354KB)

Option Care Enterprises, Columbia, MD

FMD-145 Letter Issued 4/23/2020 (PDF-232KB)
State Referral Letter Issued 4/23/2020 (PDF-196KB)
Amended Warning Letter (07/20/2017)
483 Issued 06/28/2016 (PDF - 1.2MB)

Option Care Enterprises Inc. Everett WA

483 Issued 05/19/2017 (PDF - 100KB)
Warning Letter (09/07/2016)
483 Issued 02/25/2016 (PDF - 1.9MB)

Option Care, Inc., San Antonio, TX

FMD-145 issued 04/12/2018 (PDF - 79KB)
State Referral Letter Issued 04/12/2018 (PDF - 65KB)

Optum Compounding Services, LLC, Phoenix, AZ

483 Issued 08/13/2021(PDF - 1.7 MB)

Oregon Compounding Centers, Inc., (dba Creative Compounds), Wilsonville, OR

Warning Letter (01/27/2015)
Firm Press Release: Oregon Compounding Centers, Inc. Issues Voluntary Recall of Unexpired Sterile Products in Oregon and Washington Due to Lack of Sterility Assurance (10/09/2014)
483 Response Dated 10/01/2014 (PDF - 5MB)
Amended 483 Issued 09/12/2014 (PDF - 1.9MB)
483 Issued 08/28/2014 (PDF - 1.7MB)

Orsini Pharmaceutical Services, Inc., (dba Orsini Healthcare), Elk Grove Village, IL

Referral Letter to the Illinois State Board of Pharmacy Issued 10/31/2019 (PDF - 101KB)
FMD-145 Letter Issued 10/29/2019 (PDF - 102KB)
483 Issued 07/25/2018 (PDF - 67KB)

OSRX, Inc., Missoula, MT

483 Issued 09/23/2021 (PDF - 386KB)

OurPharma LLC, Fayetteville, AR

483 Issued 09/30/2021 (PDF - 445KB)

Overton Brooks VA Medical Center, Shreveport, LA

483 Issued 02/12/2020 (PDF - 4.42MB)
483 Issued 02/17/2017 (PDF - 1.8MB)

Owl Tri State Pharmacy, (see Chastains, Inc.), Clarkston, WA

Pacific Healthcare, Inc., (see BBS Pharmacy), Bellflower, CA

Pacifica Pharmacy, Torrance, CA

FMD-145 Letter Issued 07/08/2020 (PDF - 114KB)
Referral Letter to the California State Board of Pharmacy Issued 07/08/2020 (PDF - 84KB)
483 Issued 09/09/2019 (PDF - 440KB)
Warning Letter Response Dated 02/21/2008
Warning Letter (01/07/2008)

Pacifico National Inc., (dba Amex Pharmacy), Melbourne, FL

Referral Letter to Florida State Board of Pharmacy Issued 03/10/2021 (PDF - 235KB)
FMD-145 Letter Issued 05/28/2020 (PDF - 68KB)
Firm Press Release: Pacifico National, Inc. dba AmEx Pharmacy Issues Voluntary Nationwide Recall for all Lots of Bevacizumab (08/30/2019)
FDA Press Release: FDA Requests Recall of Sterile Compounded Drug Products Produced by Pacifico National Inc., dba AmEx Pharmacy, Reminds Patients and Health Care Professionals to Stop Using Due to Potential Risks (08/30/2019)
Recall Letter Issued 08/23/2019 (PDF - 720KB with Sample Letter Issued 08/02/2019 (PDF - 6.34KB)
FDA Statement: FDA Warns Patients and Health Care Professionals not to Use Sterile Products from Pacifico National Inc., dba AmEx Pharmacy (06/28/2019)
483 Issued 06/20/2019 (PDF - 3.11MB)
483 Issued 01/21/2016 (PDF - 3.2MB)

Pallimed Solutions, Inc., Woburn, MA

Warning Letter (02/19/2014)
Amended 483 and Cover Letter Issued 04/09/2013 and 483 Issued 03/29/2013 (PDF - 15.9MB)
Firm Press Release: Pallimed Solutions, Inc. Announces Voluntary Nationwide Recall of All Sterile Compounded Products Dispensed Since January 1, 2013 Due to Possible Filament Contamination (03/25/2013)

Palm Beach Compounding, (see DNA Pharmacy Services, Inc.), Jupiter, FL

Panorama Compounding Pharmacy, Lake Balboa, CA

Warning Letter (01/07/2008)

Paradigm Healthcare Solutions, LLC, (dba Athena Pharmacy), Mount Juliet, TN

Referral Letter to the Tennessee State Board of Pharmacy Issued 09/13/2019 (PDF - 71KB)
FMD-145 Letter Issued 09/13/2019 (PDF - 61KB)

Park Compounding, (see South Coast Specialty Compounding, Inc.), Irvine, CA

Park Compounding Pharmacy, (see Chen Shwezin, Inc.), Westlake Village, CA

Park Infusioncare LP (dba Preferred Homecare), Dallas, TX

Warning Letter (03/01/2018)
483 Issued 07/11/2017 (PDF - 553 KB)

Park Infusioncare LP (dba Preferred Homecare), Houston, TX

483 Issued 02/17/2017 (PDF - 615 KB)

Park Irmat Corp. (dba Irmat Pharmacy), New York, NY

Closeout Letter Issued 05/18/2016 (PDF - 120KB)

Partell Specialty Pharmacy, (see One Way Drug, LLC), Las Vegas NV

Partners in Care Inc., Gainesville, GA

State Referral Letter Issued 10/31/2017 (PDF - 79KB)
483 Issued 03/07/2017 (PDF - 209KB)
483 Issued 06/10/2016 (PDF - 819KB)

Pathway Pharmacy, (see Avenue Pharmacy, Inc.), Ocala, FL

Pavilion Compounding Pharmacy, Atlanta, GA

Untitled Letter Issued 11/06/2020 (PDF - 277KB)
483 Response Dated 02/27/2019 (PDF - 2.53MB)
483 Issued 02/08/2019 (PDF - 717KB)

PCP LV LLC, (dba Pinnacle Compounding Pharmacy), Las Vegas, NV

Warning Letter (05/23/2016)
483 Issued 7/31/2015 (PDF - 800KB)

Pencol Pharmacy, (see Maplerose Enterprises, LLC), Denver, CO

Pensacola Apothecary Inc., (dba Everwell Specialty Pharmacy), Pensacola, FL

FMD-145 Letter Issued 04/22/2019 (PDF - 61KB)
Referral Letter to the Florida State Board of Pharmacy Issued 04/22/2019 (PDF - 54KB)
Warning Letter CloseOut (04/22/2019)
Warning Letter 6/28/2017
483 Response Dated 09/19/2016 (PDF - 1.5MB)
483 Issued 08/31/2016 (PDF - 1.1MB)

Pentec Health, Inc., 9 Creek Parkway, Boothwyn, PA

FMD-145 Letter Issued 04/09/2020 (PDF - 74KB)
FMD-145 Letter Issued 08/31/2018 (PDF - 102KB)
483 Issued 02/23/2018 (PDF - 571KB)

Pentec Health, Inc., 4 Creek Parkway, Boothwyn, PA

State Referral Letter Issued 03/12/2018 (PDF - 79KB)
FMD-145 Letter Issued 03/12/2018 (PDF - 88KB)
Referral Letter to the Pennsylvania State Board of Pharmacy Issued 05/05/2017 (PDF - 318KB)
FMD-145 Letter Issued 05/05/2017 (PDF - 618KB)
Warning Letter (03/07/2014)
Firm Press Release: Pentec Health Announces Limited Voluntary Recall of Certain Compounded Prescription Therapies for Renal Patients (05/15/2013)
483 Issued 04/01/2013 (PDF - 924KB)

People's Custom Rx and Clinical Care, LLC, Memphis, TN

483 Issued 08/05/2021 (PDF - 1.05MB)
FMD-145 Letter Issued 05/20/2020 (PDF - 199KB)
483 Issued 07/24/2019 (PDF - 390KB)
483 Issued 07/19/2018 (PDF - 441KB)
483 Issued 07/02/2018 (PDF - 408KB)
Warning Letter (06/06/2016)
483 Response Dated 08/13/2015 (PDF - 440KB)
483 Issued 07/29/2015 (PDF - 942KB)

People's Pharmacy, Inc. #1, Austin, TX

483 Issued 12/07/2017 (PDF - 306KB)

People's Pharmacy, Inc. #2, Austin, TX

Referral Letter to the Texas State Board of Pharmacy Issued 03/12/2019 (PDF - 65KB)
FMD-145 Letter Issued 03/12/2019
483 Issued 12/07/2017 (PDF - 510KB)
483 Issued 07/28/2014 (PDF - 560KB)

Perry Drugs Inc., Overland Park, KS

Referral Letter to the Kansas State Board of Pharmacy Issued 03/29/2017 (PDF - 200KB)
Closeout Letter Issued 11/18/2016 (PDF - 155KB)
Warning Letter (02/03/2015)
483 Issued 09/09/2014 (PDF – 821KB)

Pharmaceutical Care Solutions dba Pharmacy Solutions, Ann Arbor, MI

Warning Letter (08/02/2021)

Pharmaceutic Labs, LLC, Albany, NY

Warning Letter (05/03/2017)
483 Issued 09/23/2015 (PDF - 516KB)

Pharmacy Acquisition Co., LLC, (dba NewEra Pharmacy, LLC), Portland, OR

FMD-145 Letter Issued 04/30/2020 (PDF - 60KB)
483 Issued 11/27/2019 (PDF - 626KB)

Pharmacy Associates, Inc., Huntington, WV.

483 Issued 05/24/2017 (PDF - 7.1MB)

Pharmacy Compounding Specialties, Dallas, TX

Warning Letter (01/07/2008)

Pharmacy Creations, Randolph, NJ

483 Issued 09/30/2015 (PDF - 368KB)
Firm Press Release: Pharmacy Creations Issues Voluntary Recall of Four Product Lots With Limited Distribution in Florida, New Jersey, New York, and Puerto Rico Due to Potential Non-Sterility (09/04/2014)
Warning Letter (06/23/2014)
483 Response Dated 09/03/2013 (PDF - 39KB)
483 Issued 08/19/2013 (PDF - 1.3MB)

Pharmacy Doctors Enterprises (dba Zion Clinical Pharmacy), Hallandale Beach, FL

Untitled Letter Issued 08/17/2018 (PDF - 85KB)
483 Issued 11/20/2017 (PDF - 445KB)

Pharmacy Plus, Inc. (dba Vital Care Compounder LLC), Hattiesburg, MS

483 Issued 05/16/2019 (PDF - 786KB)
Warning Letter (08/09/2017)
483 Issued 07/07/2016 (PDF - 1.5MB)

Pharmacy Resources Incorporated, Denver, CO

483 Issued 01/29/2019 (PDF - 1.2MB)
Warning Letter (03/01/2018)
483 Issued 05/23/2017 (PDF - 1.3MB)

Pharmacy Specialists of Central FL Inc., (dba Pharmacy Specialists), Altamonte Springs, FL.

FMD-145 Issued 06/03/2018 (PDF - 47KB)
State Referral Letter Issued 06/03/2018 (PDF - 53KB)
483 Issued 06/08/2017 (PDF - 251KB)

Pharmagen Laboratories, Inc, Stamford, CT

Amended 483 Issued 08/26/2013 (PDF - 1.1MB)
483 Issued 08/23/2013 (PDF - 1.1MB)

Pharmagen Laboratories, Silver Spring, MD

Warning Letter (10/24/2014)

Pharmakon Compounding Pharmacy Inc., Noblesville, IN

Warning Letter (09/07/2017)
483 Issued 05/06/2016 (PDF - 1.9MB)

Pharmakon Long Term Care Pharmacy Inc., Noblesville, IN

Referral Letter to the Indiana State Board of Pharmacy Issued 03/06/2017 (PDF - 473KB)
483 Issued 05/11/2016 (PDF - 1.4MB)

Pharmakon Pharmaceuticals, Inc., Noblesville, IN

DOJ Press Release: Pharmacy Owner and Director of Compliance Charged with Defrauding United States and Distributing Adulterated Drugs (June 22, 2017)
Firm Press Release: Pharmakon Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of All Sterile Compounded Products Due to FDA Concern of Lack of Sterility Assurance (04/19/2016)
FDA Statement: FDA Alerts Health Care Professionals not to Use Sterile Drug Products from Pharmakon Pharmaceuticals, Inc., Noblesville, Indiana (04/15/2016)

Amended 483 issued 03/21/2016 (PDF - 3.5MB)
483 issued 03/16/2016 (PDF - 3.4MB)
FDA Statement: FDA Announces Pharmakon Pharmaceuticals Voluntary Recall of Morphine Sulfate 0.5 mg/mL Preservative Free in 0.9% Sodium Chloride (02/16/2016)
Warning Letter (05/21/2015)
483 Issued 04/08/2014 (PDF – 350KB)
483 Issued 03/13/2014 (PDF – 1.9MB)

PharmaLogic CSP, Inc., Bridgeport, WV

Warning Letter (04/29/2016)
483 Issued 12/12/2014

Pharmaview, Inc., (dba Far Hills Pharmacy), Bedminster, NJ

FMD-145 Letter Issued 07/16/2020 (PDF - 139KB)
483 Issued 11/14/2019 (PDF - 392KB)

Pharmcore Inc. (dba Hallandale Pharmacy), Hallandale, FL

483 Issued 09/24/2021 (PDF - 420KB)
Warning Letter (03/11/2020)
483 Issued 07/13/2018 (PDF - 1.38MB)

Pharm D Solutions, LLC, Houston, TX

FDA Press Release: Federal court enters consent decree against Texas compounder, Pharm D Solutions, LLC to cease the manufacturing of drugs intended to be sterile due to insanitary conditions (05/22/2019)
FDA Statement: FDA Alerts Health Care Professionals and Patients not to Use Sterile Drug Products from Pharm D Solutions (11/19/2018)
Firm Press Release: Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance (9/10/2018)
483 Issued 08/28/2018 (PDF - 4.5MB)
Warning Letter (12/08/2016)
483 Issued 06/05/2015 (PDF - 585KB)

PharMEDium Services, LLC, Lake Forest, IL

FDA Press Release: Federal Judge Enters Consent Decree Against Compounder PharMedium Services for Violations at Multiple Facilities (5/22/2019)
483 Issued 04/11/2018 (PDF - 2MB)
Firm Press Release: PharMEDium Services Issues Voluntary Nationwide Recall of Specific Lots of Potassium Phosphate and Succinylcholine Chloride Due to a Lack of Sterility Assurance (06/26/2017)
Firm Press Release: PharMEDium Issues Voluntary Nationwide Recall Sterile Preparations Compounded With a Single Recalled Lot of Fresenius Kabi Sensorcaine-MPF (bupivacaine HCl) Due to the Presence of Glass Particulate Matter (05/05/2016)
483 Issued 01/04/2016 (PDF - 1.2MB)
Firm Press Release: Pharmedium Issues Voluntary Nationwide Recall of 4mg Norepinephrine Bitartrate (16mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 8mg Norepinephrine Bitartrate (32mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag for Discoloration (12/31/2015)
Warning Letter (07/18/14)
FDA letter to PharMEDium (02/05/13)

PharMEDium Services, LLC, Cleveland, MS

483 Issued 01/05/2018 (PDF - 2.9MB)
483 Issued 07/16/2015 (PDF - 635KB)
Warning Letter (07/18/14)
483 Issued 02/22/2013 (PDF – 1.9MB)

PharMEDium Services LLC, Dayton, NJ

483 Issued 12/13/2017 (PDF - 2.4MB)
483 Issued 05/26/2016 (PDF - 1.5MB)

PharMEDium Services LLC, Edison, NJ

483 Issued 07/13/2015 (PDF - 1.1MB)
Warning Letter (07/18/14)
483 Issued 02/28/2013 (PDF - 2MB)

PharMEDium Services LLC, Memphis, TN

Firm Press Release: Pharmedium Services, LLC Expands Voluntary Nationwide Recall of Additional Lots of Compounded Sterile Products Within Expiry Due to Lack of Sterility Assurance (01/11/2018)
Firm Press Release: PharMEDium Services, LLC Issues Voluntary Nationwide Recall of Certain Lots of Compounded Sterile Products due to Lack of Sterility Assurance (12/27/2017)
483 Issued 12/15/2017 (PDF - 3.8MB)
483 Issued 07/10/2015 (PDF - 1.5MB)
Warning Letter (07/18/14)
483 Issued 03/22/2013 (PDF - 10.4MB)

PharMEDium Service, Inc., Sugar Land, TX

483 Issued 12/22/2017 (PDF - 2MB)
Firm Press Release: PharMEDium Services, LLC Issues Voluntary Nationwide Recall of all unexpired lots of Oxytocin Compounded with Either Lactated Ringers or Lactated Ringers and Dextrose Due to Sub-Potency (09/01/2017)
483 Issued 09/24/2015 (PDF - 898KB)
Warning Letter (07/18/14)
483 Issued 02/27/2013 (PDF – 1.1MB)

PharMerica LLC, Indianapolis, IN

FMD-145 issued 02/21/2018 (PDF - 89KB)
State Referral Letter issued 02/21/2018 (PDF - 83KB)
483 Issued 02/23/2017 (PDF - 723KB)

PharmScript LLC, Somerset, NJ

Referral Letter to the New Jersey State Board of Pharmacy Issued 07/29/2019 (PDF - 116KB)
FMD-145 Letter Issued 07/29/2019 (PDF - 104KB)
483 Issued 08/07/2018 (PDF - 640KB)
Warning Letter (08/23/2017)
483 Issued 10/24/2016 (PDF - 625KB)

Physician Preferred Medical, LLC, (dba PPM Pharmacy), Oklahoma City, OK

Referral to the Oklahoma State Board of Pharmacy Issued 07/28/2017 (PDF - 72KB)
Warning Letter (01/20/2016)
483 Issued 02/19/2015 (PDF - 1.6MB)

Piedmont Hospital, Inc., (dba Phcy-Corp), Atlanta, GA

Referral Letter to the Georgia State Board of Pharmacy Issued 08/14/2020 (PDF - 316KB)
FMD-145 Letter Issued 08/14/2020 (PDF - 192KB)
483 Issued 02/18/2020 (PDF - 156KB)

Pine Pharmaceuticals, Tonawanda, NY

483 Issued 05/14/2021 (PDF - 1.47MB)
483 Issued 04/26/2018 (PDF - 783KB)
Warning Letter (11/07/2016)
483 Issued 10/09/2015 (PDF - 580KB)

Pine Pharmacy and Home Care Products Center, Inc., (dba Pine Pharmacy), Williamsville, NY

FMD-145 Letter Issued 04/25/2019 (PDF - 104KB)
Referral Letter to New York State Board of Pharmacy Issued 11/07/2016 (PDF - 431KB)
483 Issued 04/18/2016 (PDF - 850KB)
Warning Letter (02/13/2015)
483 Issued 12/16/2013 (PDF – 5.3MB)
483 Issued 7/19/2013 (PDF – 1.4MB)

Pinnacle Compounding, Missoula, MT

483 Issued 04/25/2019 (PDF - 278KB)

Pinnacle Compounding Pharmacy, (see PCP LV LLC), Las Vegas, NV

Plainsboro Pharmacy, Plainsboro, NJ

Referral Letter to the New Jersey State Board of Pharmacy Issued 01/11/2017 (PDF - 62KB)
Warning Letter (08/01/2016)

Portage Pharmacy, Inc., Portage, MI

Referral Letter to Michigan Board of Pharmacy Issued 02/25/2014 (PDF - 357KB)
483 Issued 03/06/2013 (PDF - 8.9MB)

Portland Compounding Pharmacy, LLC, (dba Lloyd Central Compounding Pharmacy), Portland, OR

FMD-145 Letter Issued 04/07/2020 (PDF - 69KB)
483 Issued 11/26/2019 (PDF - 309KB)

Post Haste Pharmacy, (see Lato Drug Company), Hollywood, FL

Potter’s House Apothecary, Inc.

Final Notice (PDF - 165 KB)
483 Issued 9/16/2020 (PDF - 5 MB)

Poulsbo Compounding Pharmacy, LLC, (dba Cascade Specialty Pharmacy), Poulsbo, WA

Untitled Letter Issued 10/09/2020 (PDF - 584KB)
483 Issued 04/17/2019 (PDF - 710KB)

PPM Pharmacy, (see Physician Preferred Medical, LLC), Oklahoma City, OK

PrecisionMed Pharmacy, Tampa, FL

Untitled Letter Issued 6/10/2020 (PDF-255KB)

Precision Pharmacy Center, LLC, Brea, CA

Warning Letter (11/15/2016)
483 Issued 06/10/16 (PDF - 356KB)
483 Issued 04/01/2015 (PDF - 608KB)

Preckshot Professional Pharmacy, (see Central Illinois Compounding, Inc.), Peoria Heights, IL

Preferred Homecare, (see Park Infusioncare LP), Houston, TX

Premier Pharmacy Labs, Inc., (dba Rx Nations), Weeki Wachee, FL

FDA Press Release: Federal Court Enters Consent Decree Against Florida Compounder, Prohibiting Manufacture and Distribution of Drugs Due to Insanitary Conditions (09/17/2021)
483 Issued 07/25/2019 (PDF - 3.63MB)
Firm Press Release: Premier Pharmacy Labs Issues Voluntary Nationwide Recall of all Unexpired Sterile Drug Product Lots Due to Lack of Sterility Assurance (06/18/2019)
Firm Press Release: Premier Pharmacy Labs Issues Voluntary Nationwide Recall of Specific Sterile Injectable Products Lots Due to a Potential Lack of Sterility Assurance (04/11/2018)
483 Issued 06/13/2016 (PDF - 1.4MB)
Warning Letter Response Dated 05/15/2015
Warning Letter (04/27/2015)
483 Issued 05/09/2014 (PDF – 2.5MB)

Premier Pharmacy Services, (see Good Health Inc.), Baldwin Park, CA

Prescription Alternatives, Inc., Frisco, CO

483 Issued 11/16/2018 (PDF - 3.8MB)

Prescription Dispensing Laboratories, Inc. dba PD Labs, Cedar Park, TX

Warning Letter (07/30/2019)

Prescription Lab Compounding Pharmacy, (see MFP Limited), Tucson, AZ

Prescription Labs, Inc. (dba Greenpark Compounding Pharmacy), Houston, TX

FDA Press Release: FDA alerts patients and health care professionals not to use compounded products intended to be sterile from Prescription Labs Inc. dba Greenpark Compounding Pharmacy (09/17/2021)
483 Issued 08/12/2021 (PDF - 5.66MB)
Warning Letter (10/26/2018)
483 Issued 10/27/2017 (PDF - 330KB)

President Pharmacy, (see Infupharma LLC), Hollywood, FL

Professional Arts Pharmacy, Baltimore, MD

Warning Letter CloseOut (03/11/2019)
483 Issued 12/12/2017 (PDF - 565KB)
Warning Letter (04/03/2017)
483 Issued 03/23/2016 (PDF - 1.1MB)

Professional Arts Pharmacy, (see Compounding Pharmacies of Louisiana Inc.) Lafayette, LA

Professional Compounding Pharmacy, (see Health Solutions Pharmacy Center, Inc.), Corvallis, OR

Professional Partners Inc./ Westcliff Compounding Pharmacy, Newport Beach, CA

Referral Letter to the California State Board of Pharmacy Issued 04/05/2017 (PDF - 357KB)
483 Issued 05/09/2016 (PDF - 715KB)

Professional Pharmacy Services, Inc. (dba Good Day Pharmacy), Longmont, CO

Referral Letter to the Colorado State Board of Pharmacy Issued 04/14/2020 (PDF - 83KB)
483 Issued 06/17/2019 (PDF - 554KB)
Untitled Letter Issued 01/02/2018 (PDF - 73KB)

Promise Pharmacy, LLC, Palm Harbor, FL

483 Issued 09/23/2021 (PDF - 649KB)
FDA Statement: FDA Alerts Health Care Professionals and Patients not to use Drug Products Intended to be Sterile from Promise Pharmacy (12/7/2018)
Amended 483 Issued 11/12/2018 (PDF - 1.2MB)
483 Issued 10/25/2018 (PDF - 1.09MB)

Providence Health and Services Washington, (dba Providence Infusion Hospital Services), Tukwila, WA

483 Issued 10/05/2020 (PDF - 1.46MB)

Puget Sound Drug Corporation, (dba Key Compounding Pharmacy), Federal Way, WA

483 Issued 06/13/2019 (PDF - 1.27MB)
Warning Letter (04/04/2018)
483 Issued 03/08/2017 (PDF - 1.9MB)

Pure Pharmacy, (see Front Door Pharmacy), Houston, TX

Qualgen LLC, Edmond, OK

483 Issued 06/15/2021(PDF - 2.5MB)
483 Issued 09/13/2018 (PDF - 2.2MB)
483 Issued 05/10/2017 (PDF - 982KB)
Warning Letter (06/03/2016)
FDA Statement: FDA Alerts Health Care Professionals not to Use Sterile Drug Products from Qualgen (10/10/2015)
Amended 483 Issued 09/17/2015 (PDF - 2.5MB)

Queens Express Pharmacy, Jackson Heights, NY

483 Issued 07/11/2016 (PDF - 560KB)

Quinn Pharmacy, (see North Laurel Discount Drug, Inc.), Laurel, MS

QuVa Pharma, Inc., Bloomsbury, NJ

483 Issued 05/31/2019 (PDF - 1.69MB)
483 Issued 11/30/2017 (PDF - 406KB)

QuVa Pharma, Inc. Sugar Land, TX

483 Issued 04/23/2019 (PDF - 693KB)
483 Issued 06/02/2017 (PDF - 313KB)
FMD-145 Letter Issued 03/24/2017 (PDF - 140KB)
Amended 483 Issued 02/08/2016 (PDF - 807KB)
483 Issued 02/05/2016 (PDF - 746KB)

QuVa Pharma Inc. Temple, TX

483 Issued 03/14/2019 (PDF - 1.14MB)
483 Issued 04/20/2018 (PDF - 676KB)
483 Issued 12/08/2016 (PDF - 279KB)

R & R Compounding Pharmacy, (dba Talon Compounding Pharmacy), San Antonio, TX

RAM Pharma, Inc., Idaho Falls, ID

483 Issued 08/01/2019 (PDF - 1.05MB)
Warning Letter (10/27/2017)
483 Response Dated 03/22/2017 (PDF - 3.4MB)
483 Issued 03/01/2017 (PDF - 6.4MB)

Rancho Park Compounding Pharmacy, (see Sanders Pharmaceuticals, Inc.), Los Angeles, CA

Randol Mill Pharmacy, Arlington, TX

Warning Letter (09/17/2020)
483 Issued 08/06/2019 (PDF - 874KB)

Ranier’s Compounding Laboratory, Jeannette, PA

483 Issued 08/16/2021 (PDF - 1.03MB)
FDA Press Release: Federal Court Enters Consent Decree Against Ranier's Rx Laboratory and Owner for Manufacturing Purportedly Sterile Drug Products in Unsanitary Conditions (02/06/2019)
FDA Statement: FDA Announces Ranier’s Rx Laboratory’s Voluntary Recall of All Sterile Compounded Drug (07/31/2018)
FDA Statement: FDA Alerts Health Care Professionals, Patients, Veterinarians and Animal Owners not to Use Sterile Drug Products from Ranier’s Compounding Laboratory (07/10/2018)
483 Issued 05/22/2018 (PDF - 1MB)
Warning Letter (03/28/2017)
483 Issued 04/22/2016 (PDF - 1023KB)

RC Compounding Services, LLC, Poland, OH

Referral Letter to the Ohio State Board of Pharmacy Issued 09/12/2019 (PDF - 159KB)
FMD-145 Letter Issued 09/12/2019 (PDF - 110KB)
483 Issued 02/16/2018 (PDF - 853KB)
483 Issued 09/14/2015 (PDF - 1002KB)
Warning Letter (07/14/2014)
483 Issued 02/07/2013 (PDF - 195KB)

RC Outsourcing LLC, Lowellville, OH

FMD-145 Letter Issued 05/22/2020 (PDF - 105KB)
483 Issued 02/08/2019 (PDF - 5.39MB)
Warning Letter (11/28/2017)
483 Issued 03/31/2017 (PDF - 1.1MB)
Closeout Letter Issued 07/20/2016 (PDF - 27KB)
Amended 483 Issued 02/25/2016 (PDF - 1MB)
483 Issued 02/09/2016 (PDF - 869KB)

Red Cross Drug, (see Lowlyn Pharmacies, Inc.), Blanchard, OK

Red Mountain Compounding Pharmacy, (see First Royal Care Co. LLC), Mesa, AZ

Reed Pharmacy, Inc., Sterling, KS

483 Issued 09/27/2018 (PDF - 323KB)

Reed's Compounding Pharmacy, (see Jones Drug Company, Inc.), Tucson, AZ

Region Care, Inc., Great Neck, NY

Referral to the New York State Board of Pharmacy Issued 06/15/2017 (PDF - 65KB)
483 Issued 06/10/2016 (PDF - 722KB)
Warning Letter (04/08/2015)
483 Issued 03/20/2014 (PDF – 922KB)

Reliable Drug Pharmacy, San Francisco, CA

Warning Letter (03/09/2017)
Amended 483 Issued 04/20/2016 (PDF - 2MB)
FDA Statement: FDA Announces Voluntary Recall of All Unexpired Human and Animal Compounded Drug Products Produced by Reliable Drug Pharmacy, San Francisco (03/30/2016)
Firm Press Release: Reliable Drug Recall of all Compounded Medications Due to a Potential for Mislabeling and Lack of Quality Assurance (03/25/2016)
483 Issued 03/29/2016 (PDF - 2MB)

Reliant Pharmacy, (see Yeung Business Solutions), Southbury, CT

Resource Optimization & Innovation LLC, Springfield MO

483 Issued 11/29/2016 (PDF - 851KB)

Revive RX LLC, dba Revive RX Pharmacy, Houston, TX

483 Issued 08/06/2021 (PDF - 447KB)

Right Value Drug Store, Inc., (dba Carie Boyd’s Prescription Shop), Hurst, TX

Warning Letter (09/20/2021)
483 Issued 11/12/2019 (PDF - 1.13MB)
Untitled Letter Issued 10/25/2019 (PDF - 347KB)
483 Issued 05/12/2017 (PDF - 207KB)
Warning Letter (07/25/2016)
483 Issued 12/12/2014

Riverpoint Pharmacy, (see First Pharma Associates LLC), Spokane, WA

Rocky Mountain Pharmacy Inc, Bozeman MT

Warning Letter (05/09/2019)
483 Issued 03/13/2018 (PDF - 227KB)

Roger Williams Medical Center, Providence, RI

Untitled Letter Issued (3/18/2021) (PDF - 1 MB)
483 Issued 08/14/2019 (PDF - 1 MB)

Rushmore Compounding Pharmacy), (see CSRX Inc.), Rapid City, SD

RX3 Pharmacy, (see RxSouth, LLC), Chester, VA

Rx Compounding Inc., (see Nora Apothecary and Alternative Therapies, Inc.), Indianapolis, IN

Rx Formulations, (dba Zions RX Formulations), Mesa, AZ

Referral Letter to the Arizona Board of Pharmacy Issued 03/30/2015 (PDF - 725KB)
483 Issued 12/02/2014 (PDF - 526KB)
Warning Letter (08/15/2014)
FDA Statement: FDA Confirms Contamination in Rx Formulations’ Calcium Gluconate 10% Product (02/06/2014)
483 Issued 01/09/2014 (PDF - 1.04MB)
FDA Statement: FDA Announces Rx Formulation's Voluntary Recall of Sterile Drug Products (12/13/2013)

Rx Nations, (see Premier Pharmacy Labs, Inc.), Weeki Wachee, FL

RXPress Pharmacy, (see Medicine Store Pharmacy, Inc.), Fort Worth, TX

RXQ Compounding, LLC, Athens, OH

Firm Press Release: RXQ Compounding, LLC Issues Voluntary Nationwide Recall of All Sterile Products within Expiry and Voluntarily Cessation of Production Due to the Lack of Sterility Process Assurance (06/18/2019)
483 Issued 06/06/2019 (PDF - 3MB)
483 Issued 08/08/2017 (PDF - 1.3MB)
Warning Letter (05/19/2016)
483 Issued 09/21/2015 (PDF - 1006KB)

RxSouth, LLC, (dba RX3 Pharmacy), Chester, VA

FMD-145 Letter Issued 06/26/2019 (PDF - 88KB)
Referral Letter to the Virginia Board of Pharmacy Issued 10/27/2016 (PDF - 531KB)
Amended 483 Issued 04/18/2016 (PDF - 677KB)
483 Issued 04/18/2016 (PDF - 753KB)
Warning Letter Response Dated 11/12/2014
Warning Letter (10/23/2014)
483 Issued 02/21/2014 (PDF - 5MB)
Referral Letter to Virginia Board of Pharmacy Issued 08/13/2013 (PDF - 9.4MB)
483 Issued 12/14/2012 (PDF - 5.1MB)

Rxtra Solutions, (see Beacon Hill Medical Pharmacy), Southfield, MI

Rye Beach Pharmacy, Inc., Rye, NY

FMD-145 Letter Issued 12/28/2020 (PDF - 90KB)
Untitled Letter Issued 08/25/2020 (PDF - 151KB)

Safeway, Inc., San Jose, CA

Referral Letter to the California State Board of Pharmacy Issued 09/29/2020 (PDF - 93KB)
Untitled Letter Issued 03/27/2019 (PDF - 424KB)
483 Issued 06/12/2017 (PDF - 227KB)

Saint John's Medical Plaza Pharmacy, Santa Monica, CA

Warning Letter (01/07/2008)

Sanders Pharmaceuticals, Inc. (dba Rancho Park Compounding Pharmacy), Los Angeles, CA

Referral Letter to the California State Board of Pharmacy Issued 12/27/2020 (PDF - 63 KB)
FMD-145 Letter Issued 11/27/2020 (PDF - 50KB)
483 Issued 05/07/2019 (PDF - 1.23MB)

San Diego Compounding Pharmacy, San Diego, CA

Referral Letter to the California State Board of Pharmacy Issued 07/08/2019 (PDF - 136KB)
Warning Letter (09/25/2017)
483 Issued 11/15/2016 (PDF - 275KB)

San Jose Compounding Pharmacy, (see White House Pharmacy, Inc.), San Jose, CA

SaveWay Compounding Pharmacy, Inc., Newark, DE

483 Issued 06/29/2017 (PDF - 180KB)
Warning Letter (10/04/2016)
483 Issued 10/02/2015 (PDF - 555KB)

SBH Medical LTD., Worthington, OH

FMD-145 Letter Issued 06/16/2020 (PDF - 102KB)
483 Issued 09/30/2019 (PDF - 176KB)

SCA Pharmaceuticals, LLC, Little Rock, AR

483 Issued 11/07/2019 (PDF - 724KB)
483 Issued 09/29/2017 (PDF - 1.1MB)
Warning Letter (06/25/2015)
483 Issued 04/01/2014 (PDF – 1.7MB)

SCA Pharmaceuticals, LLC., Windsor, CT

483 Issued 11/19/2019 (PDF - 1.41MB)
Amended 483 issued 03/05/2018 (PDF - 855KB)
483 issued 03/05/2018 (PDF - 828KB)
Firm press release: SCA Pharmaceuticals Issues Voluntary Nationwide Recall of Specific Products Due to Potential Contamination (10/20/2017)

Sewaren Innovative Pharmaceutical Packaging dba SIPP, Avenel, NJ

483 Issued 06/28/2016 (PDF - 399KB)
Warning Letter (05/22/2017)

Sentara Enterprises, Chesapeake, VA

483 Issued 08/06/2018 (PDF - 604KB)
Warning Letter (08/08/2016)
483 Response Dated 08/12/2015 (PDF - 3.5MB)
483 Issued 07/23/2015 (PDF - 1.1MB)

Service First Pharmacies, Inc. (dba Madison Drugs), Huntsville, AL

Referral Letter to the Alabama State Board of Pharmacy Issued 08/14/17 (PDF - 60KB)
Warning Letter (04/27/2016)

Sharp Drugs, Inc., West Hampton Beach, NY

483 Issued 07/13/2018 (PDF - 491KB)

Shertech Pharmacy, LLC, Kernersville, NC

483 Issued 07/18/2019 (PDF - 2.01MB)

Shertech Pharmacy, Easley, SC

483 Issued 07/02/2019 (PDF - 1.16MB)

Shiraz Specialty Pharmacy Inc. (dba Axis Pharmacy Northwest), Mountlake Terrace, WA

State Referral Letter to the Washington State Department of Health Issued 04/18/2018 (PDF - 82KB)
483 Issued 06/15/2017 (PDF - 717KB)

Sina LLC, (dba OncoMed (Onco 360)), Great Neck, NY

Referral Letter to New York State Board of Pharmacy Issued 04/21/2015 (PDF - 79KB)
483 Issued 08/22/2014 (PDF – 936KB)

Sincerus Florida LLC, Pompano Beach FL

FMD-145 Letter Issued 11/16/2020 (PDF - 209KB)
483 Issued 09/17/2018 (PDF - 766KB)
483 Issued 06/26/2017 (PDF - 447KB)
Warning Letter (12/21/2016)
483 Issued 07/15/2016 (PDF - 191KB)

Snyder Mark Drugs Roselle, Inc. (dba Mark Drugs Pharmacy), Roselle, IL

483 Issued 09/27/2019 (PDF - 412KB)
Warning Letter (02/27/2018)
483 Issued 05/22/2017 (PDF - 2.1MB)

Solaris Pharmacy, Inc., Decatur, TX

FMD-145 Letter Issued 07/17/2020 (PDF - 62KB)
483 Issued 02/26/2020 (PDF - 409KB)

Soleo Health, (see Biomed PA Inc.), Sharon Hill, PA

South Coast Specialty Compounding, Inc., (dba Park Compounding), Irvine, CA

Amended 483 Issued 03/14/2016 (PDF - 1.7MB)
483 Issued 03/14/2016 (PDF - 1.9MB)
Referral Letter to the California State Board of Pharmacy Issued 06/23/2015 (PDF - 985KB)
483 Issued 07/02/2014 (PDF - 708KB)
Firm Press Release: Park Compounding: Sterile Medication Recall - Concerns of Sterility Assurance at Testing Vendor (09/10/2013)

Southern California Compounding Pharmacy, LLC, San Diego, CA

FMD-145 Letter Issued 05/14/2020 (PDF - 60KB)
483 Issued 08/01/2019 (PDF - 529KB)

Specialty Compounding, LLC, Cedar Park, TX

483 Issued 05/05/2015 (PDF - 418KB)
FDA Press Release: Federal Judge Enters Consent Decree Against Specialty Compounding LLC (03/11/2015)
FDA Statement: FDA Releases Laboratory Results of Specialty Compounding Recalled Products Confirming Contamination (11/15/2013)
Firm Press Release: Clarification to News Release Issued on August 9th Specialty Compounding, LLC Issues Nationwide Voluntary Recall of All Lots of Unexpired Sterile Products Due to Reports of Adverse Events (11/15/2013)
483 Issued 09/13/2013 (PDF - 9MB)
CDC Health Advisory: Nationwide Voluntary Recall of All Products for Sterile Use from Compounding Pharmacy Located in Cedar Park, Texas (08/14/2013)
FDA Press Release: FDA Announces Nationwide Voluntary Recall of All Products for Sterile Use from Specialty Compounding (08/11/2013)
FDA Statement: FDA Alerts Health Care Professionals about Sterile Products from Specialty Compounding (08/09/2013)
Firm Press Release: Specialty Compounding, LLC Issues Nationwide Voluntary Recall of All Lots of Unexpired Sterile Products Due to Reports of Adverse Events (08/09/2013)
483 Issued 03/22/13 (PDF – 744KB)

Specialty Medicine Compounding Pharmacy, P.C., South Lyon, MI

Warning Letter (08/31/2015)
483 Issued 11/05/2013 (PDF - 3.2MB)
FDA Press Release: FDA Announces Voluntary Recall of Certain Sterile Products from Specialty Medicine Compounding Pharmacy (10/22/2013)
Firm Press Release: Specialty Medicine Compounding Pharmacy Issues Voluntary Recall of Certain Unexpired Compounded Sterile Products (10/19/2013)

Spoonamore Drug Co., Inc., (dba Louisville Pharmacy), Louisville, KY

State Referral Letter Issued 05/31/2018 (PDF - 76KB)
Warning Letter CloseOut (05/17/2018)
483 Issued 03/14/2017 (PDF - 333KB)
Warning Letter (12/18/2015)
483 Issued 02/03/2015 (PDF - 543KB)

SSM Health Care St. Louis, (dba SSM St. Clare Health Center), Fenton, MO

483 Issued 09/28/2021 (PDF - 1.37MB)
483 Issued 08/28/2019 (PDF - 1.01MB)
483 Issued 11/16/2017 (PDF - 608KB)
Warning Letter (10/19/2015)
483 Issued 08/14/2014 (PDF – 711KB)

SSM St. Clare Health Center, (see SSM Health Care St. Louis), Fenton, MO

Stanley Specialty Pharmacy Compounding and Wellness Center, Charlotte, NC

483 Issued 10/01/2021 (PDF - 303KB)
Warning Letter (07/24/2018)
483 Issued 08/04/2017 (PDF - 191KB)
483 Issued 07/07/2016 (PDF - 373KB)

STAQ Pharma, Inc., Denver, CO

483 Issued 09/29/2021 (PDF - 3.24MB)
483 Issued 09/03/2020 (PDF - 877KB)

SterRx, Plattsburgh, NY

483 Issued 11/04/2021 (PDF - 6.46MB)
FMD-145 Letter Issued 07/07/2020 (PDF - 212KB)
Untitled Letter Issued 10/17/2018 (PDF - 101KB)
483 Issued 03/17/2017 (PDF - 779KB)

Steven's Pharmacy, Costa Mesa, CA

Warning Letter (11/12/2008)

Stewart Compounding Pharmacy, Fayetteville, NC

483 Issued 10/10/2014 (PDF - 1.5MB)
483 Issued 02/26/2014 (PDF - 1.4MB)
Warning Letter (08/21/2013)
483 Issued 03/25/2013 (PDF - 7.3MB)

Stokes Healthcare Inc., (dba Stokes Pharmacy), Mount Laurel, NJ

483 Issued 10/09/2020 (PDF - 603KB)
483 Issued 06/19/2018 (PDF - 569KB)
Referral Letter to the New Jersey State Board of Pharmacy Issued 01/03/2017 (PDF - 421KB)
Closeout Letter Issued 8/31/2016 (PDF - 263KB)
483 Response Dated 04/01/2016 (PDF - 2.2MB)
483 Issued 02/12/2016 (PDF - 497KB)

Stonegate Pharmacy LP, Austin TX

FMD-145 Letter Issued 09/21/2020 (PDF - 121KB)
Referral Letter to the Texas State Board of Pharmacy Issued 09/21/2020 (PDF - 210KB)
483 Issued 08/09/2019 (PDF - 1.48MB)
FMD-145 Letter Issued 04/24/2019 (PDF - 47KB)
Referral Letter to the Texas State Board of Pharmacy Issued 04/24/2019 (PDF - 69KB)
483 Issued 06/11/2018 (PDF - 502KB)
Warning Letter (11/10/2016)
Amended 483 Issued 03/02/2016 (PDF - 6MB)
483 Issued 03/02/2016 (PDF - 5.5MB)

Stone Oak Pharmacy LP, San Antonio, TX

FMD-145 Letter Issued 03/14/2019 (PDF - 318KB)
Untitled Letter Issued 11/22/2017 (PDF - 1010KB)

Strohecker's Pharmacy, Portland, OR

Warning Letter (09/18/2017)
483 Issued 10/04/2016 (PDF - 1.1MB)

Summerton Drugs Compounding and Dispensary LLC dba Summerton Drugs, Summerton, SC

Referral Letter to the South Carolina Department of Labor and Licensing- Board of Pharmacy Issued 02/15/2017 (PDF - 288KB)
483 Issued 10/17/2014 (PDF - 493KB)

Surgery Pharmacy Services, Inc., Chattanooga, TN

483 Issued 12/06/2019 (PDF - 755KB)
Warning Letter (10/09/2020)

Synergy Pharmacy Services, Palm Harbor, FL

Referral to the Florida State Board of Pharmacy Issued 07/28/2017 (PDF - 83KB)
Firm Press Release: Synergy Rx Pharmacy Issues Voluntary Nationwide Recall of All Lots of HCG (Human Chorionic Gonadotropin)Freeze Dried Vials Due to a Lack of Sterility Assurance (02/14/2017)
483 Issued 06/21/2016 (PDF - 1003KB)

Synthetopes, Inc., Conway, SC

483 Issued 05/16/2019 (PDF - 1.40MB)

Tailor Made Compounding, LLC, Nicholasville, KY

Warning Letter (04/01/2020)
483 Issued 10/24/2018 (PDF - 1.7MB)
Amended 483 Issued 10/24/2018 (PDF - 2.5MB)

Tailstorm Health, Inc., Chandler, AZ

483 Issued 07/21/2021 (PDF - 1.24MB)

Talon Compounding Pharmacy, (see R & R Compounding Pharmacy), San Antonio, TX

483 Issued 08/03/2018 (PDF - 880KB)
Warning Letter (10/03/2017)
Firm Press Release: Talon Compounding Pharmacy Issues Voluntary Nationwide Recall of HCG and Sermorelin Due to Lack of Sterility Assurance (07/22/2016)
483 Issued 06/29/2016 (PDF - 2.2MB)
483 Issued 06/24/2015 (PDF - 1.5MB)

Talon Pharmacy of Boerne, (see Vita Pharmacy, LLC), Boerne, TX

Techni Med, Inc., (dba The Compounder), Aurora, IL

FMD-145 Letter Issued 05/05/2020 (PDF - 101KB)
Referral Letter to the Illinois State Board of Pharmacy Issued 05/05/2020 (PDF - 106KB)
483 Issued 10/10/2019 (PDF - 553KB)
483 Issued 01/26/2018 (PDF - 1.7MB)
Warning Letter (07/29/2016)
483 Issued 07/09/2015 (PDF - 1001KB)

The Apothecary Shoppe, LLC, Tulsa, OK

Warning Letter (08/19/2016)
483 Issued 03/13/2015 (PDF - 1.3MB)

The Compounder, (see Techni Med, Inc.), Aurora, IL

The Compounding Pharmacy, Hickory, NC

483 Issued 09/29/2021 (PDF - 194KB)
Warning Letter (06/05/2020)

The Compounding Pharmacy of America, Knoxville, TN

483 Issued 02/01/2018 (PDF - 222KB)
Warning Letter (06/09/2016)
483 Response Dated 06/26/2015 (PDF - 1.5MB)
483 Issued 05/21/2015 (PDF - 300KB)

The Compounding Pharmacy of Beverly Hills, Beverly Hills, CA

FMD-145 Letter Issued 01/13/2021 (PDF - 66KB)

The Compounding Shop, St. Petersburg, FL

Warning Letter (08/12/2014)
FDA Statement: FDA Alerts Patients and Health Care Providers Not to Use Budesonide Solution from The Compounding Shop (09/27/2013)
483 Issued 09/03/2013 (PDF - 97KB)
FDA Press Release: FDA Alerts Health Care Providers of Lack of Sterility Assurance of Drug Products from The Compounding Shop (05/08/2013)
Firm Press Release: In Cooperation with FDA, The Compounding Shop, LLC Declares a Voluntary Recall of All Lots of Sterile Compounded Products Due to a Lack of Sterility Assurance Distributed Within its Local Market Area (05/06/2013)
Amended 483 Issued 03/25/2013 (PDF - 10MB)
483 Issued 03/22/2013 (PDF - 1.3MB)

The Medicine Shoppe, (see Wood's Pharmacy, Inc.), Boones Mill, VA

The Medicine Shoppe Pharmacy, Port Charlotte, FL

Warning Letter (09/17/2021)
483 Issued 03/16/2020 (PDF - 1.07MB)

The Pet Apothecary LLC, Milwaukee, WI

483 Issued 08/07/2018 (PDF - 1.14MB)

The Prescription Center, Fayetteville, NC

FDA Press Release: FDA Alerts Health Care Professionals and Patients not to Use Products from the Prescription Center Pharmacy in Fayetteville, N.C. (04/02/2015)
NCBOP Press Release: North Carolina Board of Pharmacy Announces a Recall of All Lots of Non‐ Sterile and Sterile Products Compounded, Repackaged, and Distributed by Prescription Center Between September 10, 2014 and March 10, 2015 Due to Lack of Sterility, Potency, and Stability Assurance (04/01/2015)

The Ritedose Corporation, Columbia, SC

483 Issued 03/18/2022 (PDF - 289KB)

The Sullivan Pharmacy, (see John's Pharmacy, Inc.), Sullivan, IL

The Wellness Center Pharmacy, Inc., (dba Designer Drugs), Chattanooga, TN

Referral Letter to the Tennessee Board of Pharmacy Issued 02/06/2019 (PDF - 54KB)
FMD-145 Letter Issued 02/06/2019 (PDF - 47KB)
483 Firm Response Dated 12/27/2017 (PDF - 848KB)
483 Issued 12/22/2017 (PDF - 323KB)
Warning Letter (08/05/2016)
483 Firm Response Dated 06/17/2015 (PDF - 6.7MB)
483 Issued 05/28/2015 (PDF - 1.2MB)

The Wellness Corner, Prairieville, LA

FMD-145 Letter Issued 06/08/2018 (PDF - 47KB)
State Referral Letter Issued 06/08/2018 (PDF - 47KB)

The Wellness Pharmacy, LLC, (see J.W. Platt, RPh LLC.), Winchester, VA

483 Issued 05/16/2017 (PDF - 1.6 MB)
Warning Letter (03/23/2016)
483 Response Dated 03/16/2015 (PDF - 359KB)
483 Issued 03/12/2015 (PDF - 672KB)

Thrifty White Drug #762, Minneapolis, MN

FMD-145 Letter Issued 05/27/2020 (PDF - 96KB)
483 Issued 09/21/2018 (PDF - 689KB)

Thrive Pharmacy, (see Matthew 7:25 Inc), Jacksonville, FL

Tiberius, Inc., dba Custom Scripts Pharmacy, Wesley Chapel, FL.

FMD-145 Letter Issued 05/08/2018 (PDF - 63KB)
483 Issued 05/18/2017 (PDF - 467KB)

Total Pharmacy Services, Houma, LA

483 Issued 09/30/2014 (PDF - 514KB)
Warning Letter (02/28/2014)
483 Issued 05/22/2013 (PDF - 311KB)

Total Vein Pharmacy, LLC, (dba Total Vein Pharmacy), Houston, TX

483 Issued 05/09/2019 (PDF - 219KB)

Tower Pharmacy and Compounding, (see Botrosons Pharmaceutical Inc.), Mission Viejo, CA

Town and Country Compounding and Consultation Services LLC, Ridgewood, NJ

FMD-145 Letter Issued 08/11/2020 (PDF - 104KB)
483 Issued 12/11/2018 (PDF - 781KB)
Warning Letter (10/17/2017)
483 Issued 08/22/2016 (PDF - 1.1MB)

Town Total Compounding Center, Melville, NY

Referral Letter to the New York State Board of Pharmacy Issued 01/09/2017 (PDF - 315KB)
FMD-145 Letter Issued 12/14/2016 (PDF - 225KB)
483 Issued 04/20/2016 (PDF - 1.1MB)

Transdermal Therapeutics, Inc., Birmingham, AL

Closeout Letter Issued 05/27/2016 (PDF - 346KB)
483 Response Dated 10/14/2014 (PDF - 952KB)
483 Issued 06/27/2014 (PDF - 413KB)

Triad Isotopes, Inc., (see Jubilant Draximage Radiopharmacies, Inc.), Kansas City, MO

Triad Rx, Inc., Daphne, AL

Warning Letter (02/05/2019)
483 Issued 07/21/2017 (PDF - 516KB)

Triangle Compounding, Cary, NC

FMD-145 Issued 6/17/2020 (PFD-91KB)
483 Issued 07/13/2017 (PDF - 2.2MB)
Warning Letter (11/02/2015)
483 Issued 01/16/2015 (PDF - 484KB)
483 Issued 09/22/2014 (PDF - 1MB)
Warning Letter (01/14/2014)
483 Issued 03/01/2013 (PDF - 880KB)

Tri-Coast Pharmacy Inc., Juno Beach, FL

Warning Letter (08/20/2018)
483 Issued 10/21/2016 (PDF - 945KB)
Firm Press Release: Tri-Coast Pharmacy Inc. Voluntarily Recalling All Sterile Products Prepared Between May 17, 2016 and November 17, 2016 Due to Concern Over Lack of Sterility Assurance (11/21/2016)

Tri-Med, Inc., (dba Advanced Care Infusion-Shelby), Shelby Township, MI

State Referral Letter Issued 05/01/2018 (PDF - 77KB)
483 Issued 07/11/2017 (PDF - 615KB)
Warning Letter (12/18/2015)
483 Response Dated 03/12/2015 (PDF - 2.1MB)
483 Issued 02/23/2015 (PDF - 1.6MB)

Trinity Care Solutions (see Franck's Lab, Inc.), Ocala, FL

Trone Health Services, Inc. (Medicap Pharmacy), Meridian, ID

FMD-145 Letter Issued 07/19/2018 (PDF - 55KB)
State Referral Letter Issued 07/19/2018 (PDF - 61KB)
483 Issued 11/21/2017 (PDF - 210KB)
Warning Letter (03/22/2017)
483 Response Dated 08/03/2016 (PDF - 11.1MB)
483 Issued 07/15/2016 (PDF - 1.2MB)

TSDR Pharmacy, Inc. (dba brandMD Skin Care), Chatsworth, CA

Warning Letter (11/09/2017)
483 Issued 03/28/2017 (PDF - 608KB)

UCSF Home Therapy Services, San Francisco, CA

483 Issued 09/12/2014 (PDF – 893KB)

Unique Pharmaceutical, Ltd., Temple, TX

Closeout Letter Issued 12/11/2015 (PDF - 328KB)
483 Issued 01/23/2015 (PDF - 560KB)
FDA Press Release: FDA Announces Voluntary Nationwide Recall of All Non-Expired Sterile Drugs from Unique Pharmaceuticals (7/23/2014)
Firm Press Release: Unique Pharmaceuticals, Ltd. Announces a Voluntary Nationwide Recall of all Sterile Compounded Preparations Within Their Expiry Period Due to a Lack of Sterility Assurance (07/19/2014)
FDA Statement: FDA Alerts Health Care Professionals not to Use Sterile Drugs from Unique Pharmaceuticals (07/11/2014)
FDA Requested Recall Letter 07/11/2014 (PDF – 754KB)
483 Issued 06/20/2014 (PDF - 1MB)
Amended 483 Issued 04/04/2014 (PDF - 4.3MB)
483 Issued 04/02/2014 (PDF - 748KB)

United Pharmacy, LLC, West Palm Beach, FL

Warning Letter (02/11/2019)
Compounding Risk Alert: FDA investigates two adverse events associated with United Pharmacy’s compounded glutamine, arginine, and carnitine product for injection (11/8/2017)
483 Issued 08/18/2017 (PDF - 1MB)

University Compounding Pharmacy, (see Diversified Pharmacy Inc.), Troy, MI

University of Michigan, Ann Arbor, MI

Warning Letter (09/28/2017)
483 Issued 06/29/2016 (PDF - 1.3MB)

University of Washington Medical Center Inpatient Pharmacy, Seattle, WA

Referral Letter to Washington State Board of Pharmacy Issued 08/01/2017 (PDF - 103KB)
483 Response Dated 08/24/2016 (PDF - 651KB)
483 Issued 08/04/2016 (PDF - 1.2MB)

University Pharmacy, Inc., Salt Lake City, UT

Referral Letter to Utah State Board of Pharmacy Issued 02/20/2014 (PDF - 240KB)
483 Issued 02/26/2013 (PDF - 645KB)

University Rx Specialties Inc., San Diego, CA

483 Issued 10/27/2017 (PDF - 326KB)
Warning Letter (09/28/2016)
483 Issued 09/21/2015 (PDF - 1.5MB)

US Compounding Inc., Conway, AR

483 Issued 02/07/2019 (PDF - 2.11MB)
Warning Letter (10/10/2017)
483 Issued 07/15/2016 (PDF - 1.4MB)
Firm Press Release: US Compounding, Inc. Issues Voluntary Nationwide Recall of All Sterile Compounded Products (09/21/2015)
483 Issued 08/21/2015 (PDF - 2.3MB)
483 Issued 03/27/2014 (PDF – 1.1MB)

US Specialty Formulations LLC, Bethlehem, PA

483 Issued 07/23/2019 (PDF - 626KB)
483 Issued 08/29/2017 (PDF - 1MB)
Warning Letter (09/30/2016)
483 Issued 05/29/2015 (PDF - 1.7MB)

VA New Jersey Health Care System, East Orange, NJ

483 Issued 02/27/2020 (PDF - 885KB)

Valgene Incorporated, (dba Cape Drugs), Annapolis, MD

483 Issued 12/02/2021 (PDF - 766KB)
483 Issued 01/22/2018 (PDF - 635KB)
Warning Letter (08/12/2016)
483 Issued 10/07/2015 (PDF - 1.2MB)
FDA Statement: FDA alerts health care professionals not to use sterile drug products from Cape Apothecary, Inc., in Annapolis, MD (11/15/2015)

Vann Healthcare Services, Inc., Glasgow, KY

Vasco Pharmacy (see Vitalab Pharmacy, Incorporated), Phoenix, AZ

Village Compounding Pharmacy, Houston, TX

State Referral Letter Issued 02/02/2018 (PDF - 80KB)
FMD-145 Letter Issued 02/02/2018 (PDF - 49KB)
483 Issued 03/31/2017 (PDF - 266KB)
Warning Letter Response Dated02/19/2008
Warning Letter (01/07/2008)

Village Fertility Pharmacy, Inc., Waltham, MA

Warning Letter (02/28/2014)
483 Issued 03/13/2013 (PDF - 393KB)

Village Pharmacy, Allentown, NJ

FMD-145 Letter Issued 01/29/2021 (PDF - 88KB)
Warning Letter (10/30/2017)
483 Issued 06/22/2016 (PDF - 322KB)

Vita Pharmacy, LLC, (dba Talon Pharmacy of Boerne), Boerne, TX

483 Issued 11/02/2021 (PDF - 664KB)
483 Issued 10/06/2021 (PDF - 1.24MB)
FMD-145 Letter Issued 07/08/2020 (PDF - 208KB)
483 Issued 02/11/2020 (PDF - 640KB)

Vitalab Pharmacy, Incorporated (dba Vasco Pharmacy), Phoenix, AZ

Referral Letter to the Arizona State Board of Pharmacy dated 02/06/2020 (PDF - 79KB)
FMD-145 Issued 02/06/2020 (PDF - 68KB)
483 Issued 08/02/2019 (PDF - 169KB)
Warning Letter (01/10/2019)
483 Issued 04/04/2018 (PDF - 507KB)

Vital Care Compounder LLC, (see Pharmacy Plus, Inc.), Hattiesburg, MS

Vital Care of Dickson, Dickson, TN

Untitled Letter Issued 08/21/2020 (PDF - 429KB)
483 Issued 03/11/2020 (PDF - 405KB)

Vital Rx, Inc. dba Atlantic Pharmacy and Compounding, Pompano Beach, FL

Warning Letter (09/26/2018)
483 Issued 7/25/2017 (PDF - 945 KB)
Firm Press Release: Vital Rx, Inc. d/b/a Atlantic Pharmacy and Compounding Issues Voluntary Nationwide Recall of all Compounded Injectable Prescription Medications Due to Lack of Sterility Assurance (08/17/2017)
FDA Statement: FDA Alerts Health Care Professionals and Patients not to Use Sterile Drug Products from Vital Rx, dba Atlantic Pharmacy and Compounding (08/10/2017)

W & C (dba The Apothecary), Sartell, MN

Referral Letter to the Minnesota State Board of Pharmacy Issued 10/22/2019 (PDF - 128KB)
FMD-145 Letter Issued 10/22/2019 (PDF - 103KB)
483 Issued 07/30/2018 (PDF - 397KB)
Warning Letter (07/20/2017)
483 Issued 06/17/2016 (PDF - 957KB)

Walgreens Home Care, Inc. dba Walgreens Infusion Services, San Antonio, TX

Warning Letter (10/19/2016)
483 Issued 08/06/2015 (PDF - 821KB)

Walgreens Infusion Services, Houston, TX

Warning Letter (08/27/2015)
483 Issued 11/25/2014 (PDF - 1.1MB)

Walter's Pharmacy, Allentown, PA

State Referral Letter Issued 05/09/2018 (PDF - 70KB)
Warning Letter (01/09/2017)
483 Issued 03/01/2016 (PDF - 903KB)

Weatherford Compounding Pharmacy, LLC, Weatherford, TX

483 Issued 02/03/2012 (PDF - 460KB)

Wedgewood Connect, LLC, San Jose, CA

483 Issued 12/03/2021 (PDF - 898KB)

Wedgewood Village Pharmacy, Inc., Swedesboro, NJ

483 Response Dated 10/20/2015 (PDF - 1.1MB)
Amended 483 Issued 09/30/2015 (PDF - 1.1MB)
483 Issued 09/29/2015 (PDF - 1.3MB)
Warning Letter (02/21/2014)
483 Issued 02/11/2013 (PDF - 10.9MB)

Well Care Discount Pharmacy LLC, (dba Well Care Compounding Pharmacy), Las Vegas, NV

Untitled Letter Issued 07/17/2019 (PDF - 86KB)
483 Issued 06/27/2018 (PDF - 467KB)
Warning Letter (03/29/2017)
Firm Press Release: Well Care Compounding Pharmacy Sterile Compounded Products: Recall - Lack Of Sterility Assurance (05/18/2016)
483 Issued 05/12/2016 (PDF - 1.6MB)

Wellcare Rx Investments, (dba Denson's Specialty Pharmacy), Wheaton, IL

Warning Letter (09/30/2016)
Amended 483 Issued 01/06/2016 (PDF - 3.5MB)
483 Response Dated 12/07/2015 (PDF - 3.4MB)
483 Issued 11/19/2015 (PDF - 3.8MB)

Wellness Pharmacy, Inc., Birmingham, AL

Referral Letter to the Alabama State Board of Pharmacy Issued 04/15/2015 (PDF - 581KB)
483 Response Dated 10/20/2014 (PDF – 2.2MB)
483 Issued 09/30/2014 (PDF – 251KB)
Firm Press Release: Wellness Pharmacy, Inc. Issues Voluntary Recall of Six Medications Due to Concerns of Sterility Assurance at Testing Vendor (08/26/2013)

WellRx, LLC (dba HomeRx, LLC), Wheaton, IL

Wells Pharmacy Network, LLC, Ocala, FL

FMD-145 Letter Issued 06/8/2020 (PDF-165KB)
483 Issued 06/22/2018 (PDF - 203KB)
Firm Press Release: Wells Pharmacy Network Issues Voluntary Nationwide Recall of Sterile Products due to Concern for Lack of Sterility Assurance (09/20/2016)
483 Issued 09/13/2016 (PDF - 812KB)
Warning Letter (11/10/2014)
483 Issued 06/19/2014 (PDF - 1MB)
483 Issued 03/07/2014 (PDF - 1.2MB)
483 Issued 07/26/2013 (PDF - 1.1MB)

Wells Pharmacy Network LLC, Dyersburg, TN

483 Issued 01/28/2021 (PDF - 4.5MB)
FMD-145 Letter Issued 08/06/2020 (PDF - 67KB)
FMD-145 Letter Issued 04/15/2020 (PDF - 119 KB)
483 Issued 04/27/2018 (PDF - 3.8MB)
483 Issued 10/20/2016 (PDF - 563KB)

Wells Pharma of Houston LLC

483 Issued 06/17/2021 (PDF - 240KB)

West Coast Nuclear Pharmacy, LLC, Tampa, FL

483 Issued 03/23/2018 (PDF - 673KB)

Western Drug Inc. dba Western Drug and General Store, Springerville, AZ

Closeout Letter issued 6/12/2016 (PDF - 467KB)

Westlab Pharmacy, Inc., (dba Westlab Pharmacy), Gainesville, FL

Warning Letter (06/26/2019)
483 Issued 08/15/2018 (PDF - 902KB)

White House Pharmacy, Inc., (dba San Jose Compounding Pharmacy), San Jose, CA

483 Issued 09/14/2018 (PDF - 948KB)

Wickliffe Pharmaceutical, Inc., Lexington, KY

483 Issued 04/07/2016 (PDF - 306KB)

Wiley Chemists, Inc., Santa Fe, NM

483 Issued 10/02/2013 (PDF - 221KB)

William R. Grace M.D. P. C., New York, NY

Referral to the New York City Department of Health and Mental Hygiene Issued 08/08/2017 (PDF - 71KB)
483 Issued 07/08/2016 (PDF - 485KB)

Wingate's Pharmacy and Compounding (see Anderson Holdings Inc.), Nashua, NH

Wise Pharmacy, (see Joe Wise Pharmacy, Inc.), Littleton, CO

Woodland Hills Compounding Pharmacy, (see Algunas, Inc.), Woodland Hills, CA

Wood's Pharmacy, Inc., (dba The Medicine Shoppe), Boones Mill, VA

483 Issued 01/15/2015 (PDF 2.4MB)

Yeung Business Solutions, LLC, (dba Reliant Pharmacy), Southbury, CT

Referral Letter to the Connecticut Commission of Pharmacy Issued 03/25/2015 (PDF - 68KB)

Zion Clinical Pharmacy, (see Pharmacy Doctors Enterprises), Hallandale Beach, FL

Zions RX Formulations Services, (see Rx Formulations), Mesa, AZ

Contract Testing Laboratories

Analytical Research Laboratories, (see ARL Biopharma, Inc.), Oklahoma City, OK

ARL Biopharma, Inc., (dba Analytical Research Laboratories), Oklahoma City, OK

483 Issued 11/08/2012 (PDF - 382KB)

Boston Analytical, Inc., Salem, NH

483 Issued 11/09/2012 (PDF - 490KB)

Dyna Labs, LLC, St. Louis, MO

483 Issued 11/13/2012 (PDF - 1MB)

Eagle Analytical Services, Houston, TX

483 Response Dated 07/09/2013 (PDF - 2.8MB)
483 Issued 06/17/2013 (PDF - 984KB)

Front Range Laboratories, Inc., Loveland, CO

483 Issued 08/30/2013 (PDF - 1.6MB)
FDA Letter to Front Range Customers (PDF – 65KB) (08/23/2013)
FDA Statement: FDA Alerts Pharmacies to Concerns with Testing Conducted by Front Range Laboratories (08/21/2013)

Active Ingredient Suppliers

Darmerica LLC, Casselberry, FL

Firm Press Release: Darmerica LLC Issues Voluntary Nationwide Recall of Quinacrine Dihydrochloride Due to A Labeling Error (9/12/2019)

Medisca Inc., Saint-Laurent, Quebec, Canada, and Plattsburgh, NY

Warning Letter (11/25/2015)
Redacted 483 Issued 02/14/2014 (PDF - 175KB)
FDA Statement: FDA Lab Testing Finds N-acetyl-leucine in Samples of Recalled Medisca Product Labeled as L-citrulline (2/17/2015, 2/15/2014, and 2/14/2014)

Professional Compounding Centers of America, dba PCCA, Houston, TX

Warning Letter (01/27/2021)

Sichuan Friendly Pharmaceutical Co., Limited, China

FDA Statement: FDA Alerts Drug Makers of a Recall of Porcine Thyroid API from Sichuan Friendly Pharmaceutical Co., Limited, China (8/17/2018; updated 9/5/2018)

Suchem Laboratories, Ahmedabad, Gujarat, India

Import Alert Notification: FDA Issues Alert for all Drug Products Produced by Suchem Laboratories in India (07/09/2015)

Taizhou Xinyou Pharmaceutical & Chemical Co., Limited, Taizhou City, Zhejiang Province, China

FDA Statement: FDA Warns of Potential Contamination of Baclofen Active Pharmaceutical Ingredient from Taizhou Xinyou Pharmaceutical & Chemical Co., Limited, China (12/09/2015)

Related Information

Compounding

Resources for You

See FDA's Enforcement Report to Search Recalls, Including Compounded Drug Products Inspections, Recalls, and Other Actions with Respect to Firms that Engage in Animal Drug Compounding