Inspections, Recalls, and Other Actions with Respect to Firms that Engage in Animal Drug Compounding

Some pharmacies listed here were cited for violations of the FD&C Act relating to their human drug compounding practices but make both human and animal drugs.

Abbott's Compounding Pharmacy Inc., Berkeley, CA

483 Issued 01/08/2016 (PDF - 2MB)
Firm Press Release: Abbott's Compounding Pharmacy Issues Voluntary Recall of All Lots of Unexpired Sterile Human and Animal Compounded Products Due to Lack of Sterility Assurance (01/16/2016)
CVM Recall Initiation Date: 1/15/2016

Absolute Veterinary Compounding Pharmacy, Weatherford, TX

483 Issued 6/17/2017 (PDF – 754KB)
CVM Recall Initiation Date: 2/28/2017

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

Americare Compounding, LLC, Garden City South, NY

Warning Letter (4/22/2014)
483 Issued 6/19/2013 (PDF – 754KB)

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

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

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

CVM Recall Initiation Date: 4/02/2019
483 Issued 04/05/2019 (PDF - 1.09MB)

Atlas Pharmaceuticals, LLC, Phoenix, AZ

CVM Recall Initiation Date: 8/28/2019

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

Warning Letter (7/16/2013)
483 Issued 3/15/2013 (PDF - 638KB)
Firm Press Release - recall of all sterile drug products: 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)

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

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

483 Issued 7/19/2013 (PDF – 2.7MB)
Firm Press Release - recall of all sterile drug products: Beacon Hill Medical Pharmacy, P.C. (dba Rxtra Solutions) Issues Voluntary Nationwide Recall of Certain Sterile Products Due to a Question of Sterility Assurance (7/31/2013)
CVM Recall Initiation Date: 7/26/2013

Bedford Pharmacy, Inc., Bedford, NH

College Pharmacy Incorporated, Colorado Springs, CO

483 Issued 3/15/2013 (PDF - 1.3MB)

Colonia Care Pharmacy, Colonia, NJ

483 Issued 04/29/2019 (PDF - 601KB)
CVM Recall Initiation Date: 7/24/2019

The Compounding Shop, St. Petersburg, FL

Warning Letter (8/12/2014)
483 Issued 9/3/2013 (PDF - 97KB)
Firm Press Release - recall of all sterile drug products: 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 (5/6/2013)
Amended 483 Issued 3/25/2013 (PDF - 10MB)
483 Issued 3/22/2013 (PDF - 1.3MB)
FDA Press Release: FDA alerts health care providers of lack of sterility assurance of drug products from The Compounding Shop (5/8/2013)

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

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

FDA Requested Recall Letter Issued 9/9/2014 (PDF – 941KB)
FDA News Release: FDA reminds health care professionals and consumers not to use sterile products from Downing Labs/NuVision Pharmacy of Texas (9/9/2014)
FDA alerts health care professionals not to use sterile drugs from Downing Labs (aka NuVision Pharmacy) (7/18/2014)
483 Issued 7/16/2014 (PDF - 2.1MB)
FDA Press Release: FDA reminds health care providers not to use sterile products from NuVision Pharmacy (8/16/2013)
FDA Requested Recall Letter Issued 7/26/2013 (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 (5/18/2013)
483 Issued 4/17/2013 (PDF - 1.2MB)
Firm Press Release - recall of all sterile drug products: NuVision Pharmacy Recalls All Lots of All Lyophilized Products Compounded by NuVision (4/15/2013)

Diamondback Drugs of Delaware, LLC, Scottsdale, AZ

483 Issued 5/17/2013 (PDF - 1.1MB)
CVM Recall Initiation Date: 6/10/2013

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

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

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

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

FDA Press Release: Federal judge enters order of permanent injunction against Paul W. Franck (4/29/2016)
Warning Letter (7/9/2012)
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)
CVM Recall Initiation Date: 5/21/2012
CVM Recall Initiation Date: 5/22/2012

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

Warning Letter (8/30/2013)
Firm Press Release - recall of all sterile drug products: 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 (4/5/2013)
483 Issued 3/15/2013 (PDF - 4.9MB)

Grandpa's Compounding Pharmacy, Inc., Placerville, CA

Warning Letter (5/2/2014)
483 Issued 9/10/2013 (PDF - 1.1MB)

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

Health Innovations Pharmacy, Inc., Southern Pines, NC

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

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

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

Warning Letter (1/22/2014)
483 Issued 3/1/2013 (PDF - 1.1MB)

IV Solutions of Lubbock, Lubbock, TX

483 Response Dated 4/2/2013 (PDF - 976KB)
483 Issued 3/20/2013 (PDF - 3.7MB)

I.V. Specialty, Ltd., Austin, TX

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

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

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

483 issued 07/21/2015 (PDF 1.6MB)
CVM Recall Initiation Date: 9/3/2015

Key Pharmacy and Compounding Center (see Puget Sound Drug Corporation)

CVM Recall Initiation Date:4/18/2017

King Bio Inc.

CVM Recall Initiation Date: 8/27/2018

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)
CVM Recall Initiation Date: 9/12/2019
CVM Recall Initiation Date: 11/16/2017

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

Warning Letter (2/18/2014)
Firm Press Release - recall of all sterile drug products: 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 (5/29/2013)
483 Issued 3/21/2013 (PDF - 717KB)

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

Referral Letter to Oklahoma State Board of Pharmacy Issued 2/25/2014 (PDF - 2.4MB)
483 Issued 3/8/2013 (PDF - 732KB)

Martin Avenue Pharmacy, Inc., Naperville, IL

Warning Letter (03/18/2015)
CVM Recall Initiation Date: 9/2/2014
Firm Press Release - recall of all sterile drug products: Martin Avenue Pharmacy, Inc., Issues a Voluntary Multi-State Recall of All Compounded Sterile Preparations Due to a Lack of Assurance of Sterility (8/27/2014)
483 Issued 7/21/2014 (PDF - 1.8MB)

Med Shop Total Care, Inc., Longview, TX

483 Issued 11/01/2018 (PDF - 2.44MB)
Warning Letter (7/30/2019)

MedPark Pharmacy, LLC, Annapolis, MD

Midwest Compounders Pharmacy, Lenexa, KS

CVM Recall Initiation Date: 3/11/2015

Montana Compounding Pharmacy and Wellness Center, Missoula, MT

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

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)
CVM Recall Initiation Date: 7/24/2015

Nature's Pharmacy and Compounding Center, Asheville, NC

Warning Letter (5/9/2014)
483 Issued 11/22/2013 (PDF - 1MB)
Firm Press Release - recall of all sterile drug products: 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)
CVM Recall Initiation Date: 11/1/2013

Nora Apothecary and Alternative Therapies, Inc., Indianapolis, IN

483 Issued 8/21/2014 (PDF - 422KB)
Warning Letter (2/14/2014)
Firm Press Release - recall of all sterile drug products: Nora Apothecary & Alternative Therapies Announces a Voluntary Multi-State Recall of All Sterile Compounded Products Due to a Lack of Sterility Assurance (4/22/2013)
483 Issued 3/21/2013 (PDF - 309KB)
CVM Recall Initiation Date: 4/22/2013

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

483 Issued 11/14/2018 (PDF - 1.57MB)
CVM Recall Initiation Date: 01/2/2019

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

Oakdell Pharmacy, Inc., San Antonio, TX

483 Issued 03/29/2017 (PDF - 422KB)
Warning Letter (5/27/2014)
483 Issued 3/1/2013 (PDF - 1.1MB)

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

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 (10/9/2014)
483 Response Dated 10/01/2014 (PDF - 5MB)
Amended 483 Issued 09/12/2014 (PDF - 1.9MB)
483 Issued 8/28/2014 (PDF - 1.7MB)
CVM Recall Initiation Date: 10/6/2014

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

The Pet Apothecary LLC, Milwaukee, WI

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)
CVM Recall Initiation Date: 3/16/2015

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

483 Issued 12/16/2013 (PDF – 5.3MB)
483 Issued 7/19/2013 (PDF – 1.4MB)

Portage Pharmacy, Inc., Portage, MI

Referral Letter to Michigan Board of Pharmacy Issued 2/25/2014 (PDF - 357KB)
483 Issued 3/6/2013 (PDF - 8.9MB)

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

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)
CVM Recall Initiation Date: 06/17/2019

Prescription Alternatives, Inc., Frisco, CO

483 Issued 11/16/2018 (PDF - 3.8MB)
CVM Recall Initiation Date: 11/15/2018

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)

Professional Compounding (see Health Solutions Pharmacy), Corvallis, OR

CVM Recall Initiation Date: 2/21/2019
483 Issued 01/28/2019 (PDF - 1.3MB)

Puget Sound Drug Corporation (see Key Pharmacy and Compounding Center)

Ranier’s Compounding Laboratory, Jeannette, PA

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)
CVM Recall Initiation Date: 7/27/2018

Rapid Equine Solutions

CVM UPDATE: Compounded Unapproved Animal Drugs from Rapid Equine Solutions Linked to Three Horse Deaths (July 23, 2019)

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

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

483 Issued 06/14/2019 (PDF - 1.37MB)
CVM Recall Initiation Date: 8/06/2019

Reliable Drug Pharmacy, San Francisco, CA

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)

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

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)

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

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)
CVM Recall Initiation Date:4/23/2015

Specialty Compounding, LLC, Cedar Park, TX

CVM Update: Federal Judge enters Consent Decree against Specialty Compounding LLC
Cedar Park, TX. (03/11/ 2015)
483 Issued 9/13/2013 (PDF - 9MB)
CDC Health Advisory: Nationwide Voluntary Recall of All Products for Sterile Use from Compounding Pharmacy located in Cedar Park, Texas (8/14/2013)
FDA Press Release: FDA announces nationwide voluntary recall of all products for sterile use from Specialty Compounding (8/11/2013)
Firm Press Release - recall of all sterile drug products: Specialty Compounding, LLC Issues Nationwide Voluntary Recall of All Lots of Unexpired Sterile Products Due to Reports of Adverse Events (8/15/2013)
483 Issued 3/22/13 (PDF – 744KB)

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

CVM Recall Initiation Date: 10/19/2013
483 Issued 11/5/2013 (PDF - 3.2MB)
Firm Press Release - Recall of Certain Unexpired Compounded Sterile Products: Specialty Medicine Compounding Pharmacy Issues Voluntary Recall of Certain Unexpired Compounded Sterile Products (10/19/ 2013)

Stewart Compounding Pharmacy, Fayetteville, NC

483 Issued 2/26/2014 (PDF - 1.4MB)
Warning Letter (8/21/2013)
483 Issued 3/25/2013 (PDF - 7.3MB)

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

Firm Press Release: Stokes Healthcare Inc. Issues Voluntary Nationwide Recall of Pilocarpine 0.1% Ophthalmic Solution Due to a High Level of Preservative (March 13, 2019)
CVM Recall Initiation Date: 12/03/2018

Triangle Compounding, Cary, NC

Warning Letter (1/14/2014)
483 Issued 3/1/2013 (PDF - 880KB)

University Pharmacy, Inc., Salt Lake City, UT

Referral Letter to Utah State Board of Pharmacy Issued 2/20/2014 (PDF - 240KB)
483 Issued 2/26/2013 (PDF - 645KB

US Compounding Inc., Conway, AR

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)
CVM Recall Initiation Date:9/12/2015
CVM Recall Initiation Date:7/17/2015

Veterinary Pharmacy Corporation, Saint Peter, MN

CVM Recall Initiation Date:3/22/2016

Wedgewood Village Pharmacy, Inc. Swedesboro, NJ

Well Care Discount Pharmacy LLC, dba Well Care Compounding Pharmacy, Las Vegas, NV

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)
CVM Recall Initiation Date: 5/17/2016

Wells Pharmacy Network LLC, Ocala, FL

Firm Press Release: Wells Pharmacy Network Issues Voluntary Nationwide Recall of Sterile Products due to Concern for Lack of Sterility Assurance (09/22/2016)
483 Issued 3/7/2014 (PDF - 1.2MB)
483 Issued 7/26/2013 (PDF - 1.1MB)
CVM Recall Initiation Date: 9/21/2016

Wickliffe Pharmaceutical, Inc., Lexington, KY

Warning Letter (8/14/2014)
483 Issued 5/22/2014 (PDF - 206KB)
CVM Update: FDA Alerts Horse Owners and Veterinarians About Adverse Events Associated with Certain Unapproved Compounded Drugs in Horses (May 15, 2014)