Drug Quality Sampling and Testing Programs

Quality Sampling and Testing graphic

Programs

Drug Quality: Postmarket Sampling and Testing

FDA's requirements for approval of new and generic drugs and biologics are among the highest standards across the globe. Prior to FDA approval, the manufacturer must prove the product is safe, effective, and high quality.

To help assure safe and effective drugs are sold in the United States, we test selected drugs in FDA laboratories. This includes active pharmaceutical ingredients (API) used to make the product and the finished drug product sold to consumers. We test using the same standards that are part of the drug approval process for identity, strength, purity, and bioavailability, which is also used to establish bioequivalence.

We are committed to protecting patients from potentially unsafe, non-effective or poor-quality drugs. Postmarket surveillance testing is one way that FDA works to help ensure patients have access to safe, effective, quality drugs.

Quality

Quality Testing: Ensuring Consumer Safety

Pharmaceutical manufacturers, no matter where they are located, are responsible for ensuring that quality products reach U.S. patients. FDA’s role is to provide sufficient oversight to help ensure that companies fulfill their responsibilities and to take appropriate action when they do not.

This oversight includes testing selected finished drug products and the active ingredients used to make these products after they are on the market.

We select drug products each year based on certain criteria.

For example, we might test product samples after receiving a pattern of complaints about reduced effectiveness. These reports come to FDA via FDA's MedWatch Safety Information and Adverse Event Reporting program.

We also rely on the experience of internal and external experts to alert us to emerging safety, effectiveness, or quality issues with currently marketed drug products.

Sometimes, manufacturing or facility concerns may trigger additional FDA monitoring and testing. For instance, FDA may sample complex dosage delivery systems such as transdermal patches, drugs designed to target a specific area, and drugs that release the active ingredient in a controlled manner. FDA may also sample drugs produced by manufacturing processes that require additional controls to assure each dosage unit will perform as expected, such as delivering a precise amount of active ingredient within a narrower range, because even slight deviations could cause quality issues.

FDA also monitors certain drugs for potency concerns, which may result from faulty manufacturing processes or a short shelf life.

We use a risk-based approach to quality testing. This means that in cases where there is a known or likely safety, effectiveness, or quality issue with a product; FDA scientists perform tests specifically for this vulnerability. For example, if an active pharmaceutical ingredient has a high potential to become contaminated with a harmful impurity during the manufacturing process, FDA tests for that specific impurity.

Additional reasons products may warrant testing under the FDA’s testing program include:

The most prescribed drugs (including prescription and over-the-counter brand name and generics)
Drugs considered critical to counter terrorism attacks
Newly approved or first-time generic prescription drugs

Standards and Outcomes

Testing Standards and FDA Response to Substandard Outcomes

FDA's laboratories generally test drugs to standards set by the U.S. Pharmacopeia (USP)External Link Disclaimer , a scientific organization that sets standards for the identity, strength, quality, and purity of medicines manufactured, distributed, and consumed worldwide. These are known as monograph standards.

Typically, the monograph standards are:

Identity – is it the right drug as indicated on the label?
Assay – how much drug is there and is it consistent with the labeled amount?
Impurities – are there process impurities or degradation impurities?
Dissolution – does the active ingredient dissolve out of the dosage unit so that the drug is available for the body to absorb?

If the drug does not have a USP monograph, the FDA tests according to the methods developed by the firm and approved by FDA in the original drug application.

What does FDA do when Test Results are Substandard?

The majority of drugs FDA independently tests meet their specifications. For instance, in October through December 2013, FDA tested 70 finished drug products. Of those, two drugs did not meet their required specifications.

Over the last decade, this trend has remained steady. At the end of fiscal year 2013, there were 12,100 FDA-approved new and generic drug products (excluding biologics). From 2003 to 2013, FDA tested nearly 4,000 of these drugs. During that decade-long period, our state-of-the art laboratories found that 1.1% of the drug products analyzed deviated from acceptable standards.

When drug products have unfavorable testing results, we swiftly work to protect the public from potential harm, including providing health care professionals and consumers with information they need to make care decisions. In addition, we alert the manufacturer of the need to take measures to correct the unfavorable test results.

Our work doesn’t end following the testing. We continue to monitor the situation until the manufacturer demonstrates they are compliant with FDA rules and regulations.

FY 17 Results

Drug Name	Trade Name	Dosage Form	Firm	Tests Performed	Why Tested	Result
Amlodipine Besylate	Generic	Tablet	Zydus	Assay, Impurities	Consumer complaint: side effects related to generic amlodipine besylate	Passed Test
Amlodipine Besylate	Norvasc	Tablet	Pfizer	Assay, Impurities	Consumer complaint: side effects related to generic amlodipine besylate	Passed Test
Atracurium Besylate Injection	Atracurium	Injection	Sagent Pharmaceutical	Assay, ID, pH, Sterility, Endotoxin	Annual surveillance sampling and testing	Passed Tests
Atracurium Besylate Injection	Atracurium	Injection	Aurobindo Pharma Limited	Assay, ID, pH, Sterility, Endotoxin	Annual surveillance sampling and testing	Passed Tests
Benazepril HCl	Lotensin	Tablets	Amneal Pharmaceuticals	Assay, Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Benazepril HCl	Lotensin	Tablets	Zhejiang Huahai Pharm	Assay, Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Benazepril HCl	Lotensin	Tablets	Aurobindo Pharma Ltd	Assay, Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Bevacizumab	Avastin	Injection	Genentech	ID, Impurities	Adverse Event: inflammatory response following injection	Passed Test
Carbidopa/Levodopa	Generic	Tablet	Actavis	Dissolution	Comparison of dissolution between RLD and generic Carbidopa/Levodopa IR tablets	Passed Test
Carbidopa/Levodopa	Generic	Tablet	Mylan	Dissolution	Comparison of dissolution between RLD and generic Carbidopa/Levodopa IR tablets	Passed Test
Carbidopa/Levodopa	Generic	Tablet	Sun Pharmaceutical Industries	Dissolution	Comparison of dissolution between RLD and generic Carbidopa/Levodopa IR tablets	Passed Test
Carbidopa/Levodopa	Generic	Tablet	Teva Pharmaceuticals	Dissolution	Comparison of dissolution between RLD and generic Carbidopa/Levodopa IR tablets	Passed Test
Carbidopa/Levodopa	Generic	Tablet	Sun Pharma	Dissolution	Assessment of dissolution of Sun Pharma Cabidopa/Levodopa immediate release tablets	Passed Test
Carbidopa/Levodopa	Sinemet	Tablet	Merck	Dissolution	Comparison of dissolution between RLD and generic Carbidopa/Levodopa IR tablets	Passed Test
Celecoxib	Generic	Capsule	Apotex	Dissolution	Comparison of dissolution between RLD and generic Celecoxib capsule drug products	Passed Test
Celecoxib	Generic	Capsule	Greenstone	Dissolution	Comparison of dissolution between RLD and generic Celecoxib capsule drug products	Passed Test
Celecoxib	Generic	Capsule	Actavis	Dissolution	Comparison of dissolution between RLD and generic Celecoxib capsule drug products	Passed Test
Celecoxib	Generic	Capsule	Mylan	Dissolution	Comparison of dissolution between RLD and generic Celecoxib capsule drug products	Passed Test
Celecoxib	Celebrex	Capsule	Pfizer	Dissolution	Comparison of dissolution between RLD and generic Celecoxib capsule drug products	Passed Test
Divalproex Sodium	Depakote	Tablet	Citron Pharma	ID, assay, content uniformity, dissolution	Consumer complaint: side effects related to generic Divalproex sodium	Passed Test
Divalproex Sodium	Depakote	Tablet	Sun Pharmaceutical Industries	ID, assay, content uniformity, dissolution	Consumer complaint: side effects related to generic Divalproex sodium	Passed Test
Donepezil HCl	Generic	Tablets	Zhejiang Huahai Pharm	Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Enalapril Maleate	Generic	Tablet	Wockhardt Ltd.	Unit dose uniformity, dissolution, assay	Complaint: unit dose uniformity	Passed Test
Enalapril Maleate	Vasotec	Tablet	Valeant Pharmaceuticals International, Inc.	Unit dose uniformity, dissolution, assay	Complaint: unit dose uniformity	Passed Test
Heparin	Generic	Injectable	Sanofi	Identity and absence of contaminants	Annual surveillance sampling and testing	Passed Test
Heparin	Generic	Injectable	Gland	Identity and absence of contaminants	Annual surveillance sampling and testing	Passed Test
Heparin	Generic	Injectable	Aurobindo	Identity and absence of contaminants	Annual surveillance sampling and testing	Passed Test
Heparin	Generic	Injectable	Hospira	Identity and absence of contaminants	Annual surveillance sampling and testing	Passed Test
Heparin	Generic	Injectable	Braun	Identity and absence of contaminants	Annual surveillance sampling and testing	Passed Test
Heparin	Generic	Injectable	Fresenius Kabi	Identity and absence of contaminants	Annual surveillance sampling and testing	Passed Test
Irbesartan	Avapro	Tablets	West-Ward Columbus Inc	Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Irbesartan	Avapro	Tablets	Zhejiang Huahai Pharm	Assay, Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Lamotrigine	Generic	ER Tablets	Actavis Elizabeth LLC	Impurities, Dissolution, ID, content uniformity	Annual surveillance sampling and testing	Passed Tests
Lamotrigine	Generic	ER Tablets	Zhejiang Huahai Pharm	ID, Content Uniformity, Impurities	Annual surveillance sampling and testing	Passed Tests
Lamotrigine	Generic	Tablets	Dr. Reddy's Laboratories Ltd.	ID, Dissolution, Content Uniformity, Impurities	Annual surveillance sampling and testing	Passed Tests
Levetiracetam	Keppra	ER Tablets	Zhejiang Huahai Pharm	Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Levetiracetam	Keppra	Tablets	Mylan Pharm Inc	Content Uniformity, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Levetiracetam	Keppra	Tablets	Torrent Pharm Ltd	Content Uniformity, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Losartan Potassium	Generic	Tablets	Jubilant Cadista Pharm Inc	Assay, Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Losartan Potassium	Generic	Tablets	Torrent Pharm Ltd	Assay, Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Losartan Potassium	Generic	Tablets	Zhejiang Huahai Pharmaceutical Co., Ltd.	Assay, Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Nevirapine	Generic	Tablets	Zhejiang Huahai Pharmaceutical Co., Ltd.	Assay, Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Nevirapine	Generic	Tablets	Hetero Labs Ltd	Assay, Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Omeprazole	Generic	Capsule	Apotex	Assay, Dissolution	Consumer Complaint	Passed Test
Paroxetine	Generic	Tablets	Zhejiang Huahai Pharm	Assay, Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Paroxetine	Generic	Tablets	Cadila Healthcare Ltd	Assay, Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Ropinirole HCl	rOPINIRole	Tablets	West-Ward Columbus Inc	Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests
Ropinirole HCl	rOPINIRole	Tablets	Zhejiang Huahai Pharm	Content Uniformity, Dissolution, Impurities, ID	Annual surveillance sampling and testing	Passed Tests

FY 16 Results

FY16 Drugs (PDF - 98 KB)

FY16 Active Pharmaceutical Ingredient (PDF - 57.69 KB)

Drug Quality: Postmarket Sampling and Testing Results (FY 2016)

Test results updated bi-annually.

Drug Name	Trade Name	Dosage Form	Firm	Tests Performed	Why Tested	Results
Alprazolam	XANAX (brand)	Tablets	Pfizer Italia	Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Alprazolam	XANAX (brand)	Tablets	Pfizer Pharmaceuticals LLC	Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Alprazolam	XANAX XR (brand)	Tablets	Pharmacia and Upjohn	Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Amoxicillin	Generic	Capsules	American Antibiotics Inc.	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Amoxicillin and Clavulanate Potassium	Generic	Tablets	Dr. Reddy's Laboratories Inc.	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Amoxicillin and Clavulanate Potassium	Generic	Tablets	Lek Pharmaceuticals D.D.	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Amoxicillin and Clavulanate Potassium	Generic	Tablets	Teva Canada Ltd	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Amoxicllin and Clavulanate Potassium	Generic	Tablets	Aurobindo Pharma LTD	Dissolution , CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Ciprofloxacin	Generic	Tablets	Dr. Reddy's Laboratories Limited	Dissolution, Raman	Analysis of Drug Release and Potency Using Portable Raman Spectroscopy	Passed Test
Citalopram	Generic	Tablets	Mylan Pharmaceuticals Inc.	Assay, Dissolution, Organic Impurities, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Citalopram Hydrobromide	Generic	Tablets	Epic Pharma, LLC	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Citalopram Hydrobromide	Generic	Tablets	Invagen Pharm	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Citalopram Hydrobromide	CELEXA (brand)	Tablets	H. Lundbeck A/S	Assay, Dissolution, Organic Impurities, ID, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Clindamycin	CLEOCIN (RLD)	Capsules	Pfizer, Inc.	Assay and Impurities	Consumer Complaint: Subpotency	Passed Test
Duloxetine Hydrochloride	CYMBALTA (brand)	Tablets	Lilly del Caribe, Inc.	ID, Assay and Impurities	Foreign Online Pharmacy Surveillance	Passed Test
Erythromycin	Generic	Ophthalmic Ointment	Perrigo	Rheology, particle size, and container uniformity	Quality assessment of commercial ophthalmic ointments	Passed Test
Erythromycin	Generic	Ophthalmic Ointment	Akorn	Rheology, particle size, and container uniformity	Quality assessment of commercial ophthalmic ointments	Passed Test
Erythromycin	Generic	Ophthalmic Ointment	Bausch & Lomb	Rheology, particle size, and container uniformity	Quality assessment of commercial ophthalmic ointments	Passed Test
Ezetimibe and Simvastatin	VYTORIN (brand)	Tablets	MSD International GmbH	Assay, Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Gentamicin	GENTAK (brand)	Ophthalmic Ointment	Akorn	Rheology, particle size, and container uniformity	Quality assessment of commercial ophthalmic ointments	Passed Test
Gentamicin Sulfate	Generic	Ophthalmic Ointment	Perrigo	Rheology, particle size, and container uniformity	Quality assessment of commercial ophthalmic ointments	Passed Test
Hydralazine HCl	Generic	Tablets	Glenmark Generics Ltd	Dissolution, ID, Impurities, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Hydralazine HCl	Generic	Tablets	Hetero Drugs Limited	Dissolution, ID, Impurities, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Hydralazine HCl	Generic	Tablets	Heritage Pharmaceuticals Inc.	Dissolution, ID, Impurities, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Extended Release Tablets	Teva Pharm Industries	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Tablets	Blu Caribe Inc	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Tablets	Emcure Pharmaceuticals Limited	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Tablets	Granules Pharmaceuticals	Assay, Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Tablets	Sciegen Pharmaceuticals Inc	Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Methylphenidate Hydrochloride	CONCERTA (RLD)	Tablets & OETs	Janssen Pharmaceuticals, Inc.	Dissolution	Assess product quality	Passed Test
Methylphenidate Hydrochloride	Generic	Tablets & OETs	Mallinckrodt	Dissolution	Assess product quality	Passed Test
Metoprolol Tartrate	Generic	Tablets	Aurobindo Pharma LTD	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metoprolol Tartrate	Generic	Tablets	Emcure Pharmaceuticals Limited	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metoprolol Tartrate	Generic	Tablets	Mylan Pharm	Dissolution, ID, Impurities, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metoprolol Tartrate	Generic	Tablets	Watson Pharm	Dissolution, ID, Impurities, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metoprolol Tartrate and Hydrochlorothiazide	Generic	Tablets	Alembic Pharm	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metoprolol Tartrate and Hydrochlorothiazide	Generic	Tablets	Trigen Labs	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metronidazole	FLAGYL (brand)	Tablets	Pfizer Inc	Assay, Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metronidazole	Generic	Tablets	Teva Czech Industries	Assay, Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metronidazole	Generic	Tablets	Unichem Laboratories Ltd	Assay, Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Midazolam hydrochloride	Generic	Injection	PharMEDium	Assay and Impurities	Assess market quality	Assay Passed, Impurities Failed
Mometasone Furoate Monohydrate	NASONEX (Trade Name)	Nasal Spray	MSD International GmbH	Microbial	Assess pathogens	Passed Test
Neostigmine methylsulfate	Generic	Injection	PharMEDium	Assay and Impurities	Assess stability	Passed Test
Neostigmine methylsulfate	RLD	Injection	Fresenius Kabi	Assay and Impurities	Assess stability	Passed Test
Niacin/Simvastatin	SIMCOR (brand)	Extended Release Tablets	Abbvie Inc	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Norepinephrine Bitartrate	Generic	Injection	PharMEDium	pH Value, Assay and Impurities	Marketplace complaint on color	Failed Test
Oxcarbazepine	Generic	Tablets	Glenmark Generics Ltd	Assay, Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Oxcarbazepine	Generic	Tablets	Nexgen Pharma Inc	Assay, Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Oxcarbazepine	TRLEPTAL (Brand)	Tablets	Novartis Consumer Healthcare	Assay, Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Oxcarbazepine	Generic	Tablets	Sun Pharmaceutical Industries	Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Phenytoin Sodium	DILANTIN (RLD)	Capsules	Pfizer Ltd	Assay and Impurities	Foreign Online Pharmacy Surveillance	Passed Test
Phenytoin Sodium	DILANTIN ER (RLD)	Capsule	Pfizer	Dissolution	Performance Comparison of Dissolution Testing between RLD and Generic Phenytoin Sodium ER Drug Product	Passed Test
Phenytoin Sodium USP	Generic	Extended Release Capsule	Sun Pharma	Dissolution	Performance Comparison of Dissolution Testing between RLD and Generic Phenytoin Sodium ER Drug Product	Passed Test
Phenytoin	Generic	Extended Release Capsule	Anmeal Pharmaceuticals LLC	Dissolution	Performance Comparison of Dissolution Testing between RLD and Generic Phenytoin Sodium ER Drug Product	Passed Test
Phenytoin Sodium USP	Generic	Extended Release Capsule	Taro	Dissolution	Performance Comparison of Dissolution Testing between RLD and Generic Phenytoin Sodium ER Drug Product	Passed Test
Pioglitazone HCl and Metformin HCl	Generic	Tablets	Mylan Pharm	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Pravastatin Sodium	Generic	Tablets	Apotex Inc	Dissolution, Impurities, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Pravastatin Sodium	Generic	Tablets	Lupin Limited	Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Pravastatin Sodium	Generic	Tablets	Dr. Reddy's Laboratories Ltd	Dissolution, Impurities, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Pravastatin Sodium	Generic	Tablets	Lek Pharmaceuticals Ltd	Dissolution, Impurities, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Pravastatin Sodium	Generic	Tablets	Teva Czech Industries	Dissolution, Impurities, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Pravastatin Sodium	PRAVACHOL (brand)	Tablets	Bristol Myers Squibb Mfg Co.	Assay, Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Propafenone HCl	Generic	Tablets	Mutual Pharm Co	Assay, Dissolution, Organic Impurities, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Propafenone HCl	Generic	Tablets	Vintage Pharm (Qualitest Pharm)	Assay, Dissolution, Organic Impurities, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Propranolol HCl	Generic	Extended Release Capsules	Adare Pharmaceuticals	Assay, Dissolution, ID, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Propranolol HCl	Generic	Extended Release Capsules	Aptalis Pharmatech	Assay, Dissolution, ID, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Propranolol HCl	Generic	Tablets	Teva Czech Industries	Assay, Dissolution, ID, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Propranolol HCl	Generic	Tablets	Vintage Pharmaceuticals LLC	Assay, Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Simvastatin	Generic	Tablets	Blu Caribe	Content Uniformity	Stability inquiry	Passed Test
Simvastatin	Generic	Tablets	Dr. Reddy's Laboratories Limited	Content Uniformity	Stability inquiry	Passed Test
Simvastatin	Generic	Tablets	Dr. Reddy's Laboratories Limited	Assay, Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Simvastatin	Generic	Tablets	Intas Pharmaceuticals Inc	Assay, Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Simvastatin	ZOCOR (brand)	Tablets	Merck, Sharpe & Dohme	Assay, Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Simvastatin	Generic	Tablets	Teva Czech Industries	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Sulfacetamide sodium	Generic	Ophthalmic Ointment	Perrigo	Rheology, particle size, and container uniformity	Quality assessment of commercial ophthalmic ointments	Passed Test
Tobramycin / Dexamethasone	TOBRADEX (RLD)	Ophthalmic Ointment	Alcon	Rheology, particle size, and container uniformity	Quality assessment of commercial ophthalmic ointments	Passed Test
Venlafaxine HCl	Generic	Extended Release Capsules	Cadila Healthcare	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Venlafaxine HCl	EFFEXOR XR (brand)	Extended Release Capsules	Pfizer Ireland	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Venlafaxine HCl	Generic	Extended Release Capsules	Teva Pharm USA	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Venlafaxine HCl	Generic	Extended Release Capsules	Wockhardt Limited	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Venlafaxine HCl	Generic	Extended Release Tablets	Kremers Urban Pharmaceuticals	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Venlafaxine HCl	Generic	Tablets	Alkaloida Chemical Co Zrt	Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Venlafaxine HCl	Generic	Tablets	Mylan Pharmaceuticals	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Venlafaxine HCl	Generic	Tablets	Vintage Pharmaceuticals LLC	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test

FY 15 Results

FY15 Drugs (PDF - 93.24 KB)

FY15 Active Pharmaceutical Ingredient (PDF - 73.20 KB)

Drug Quality: Postmarket Sampling and Testing Results (FY 2015)

Test results updated bi-annually.

Drug Name	Trade Name	Dosage Form	Firm	Tests Performed	Why Tested	Results
Drug Name	Trade Name	Dosage Form	Firm	Tests Performed	Why Tested	Results
Alprazolam	XANAX XR (brand)	Extended Release Tablets	Pfizer Italia S.r.l.	Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Alprazolam	XANAX (brand)	Tablets	Pfizer Pharmaceuticals LLC	Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Amoxicillin	Generic	Capsules	American Antibiotics Inc.	Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Amoxicillin	Generic	Tablets	Teva Canada Ltd	Assay, Dissolution, ID, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Amoxicillin	Generic	Tablet	Sandoz	Assay and Raman Comparison	Consumer complaint (ineffectiveness)	Passed Test
Amphotericin B	Generic	For Injection	X-Gen Pharmaceuticals, Inc.	Assay	Assess potency	Passed Test
Brompheniramine Maleate / Pseudoephedrine Hydrochloride / Dextromethorphan Hydrobromide	BROMFED DM (RLD)	Oral Syrup	Wockhardt	Propylene Glycol content via HPLC-RI	Determine propylene glycol content	Passed Test
Buprenorphine	BUTRANS (RLD)	Transdermal	LTS Lohmann Therapie-Systeme AG	Test separation of inner disk from system	Reports that inner disk could be easily removed from generic product	Passed Test
Buprenorphine	Generic	Transdermal	Actavis Laboratories, Inc.	Test separation of inner disk from system	Reports that inner disk could be easily removed from generic product	Failed Test
Cephalexin	Generic	Capsules	Aurobindo Pharma Limited	Assay, Impurities (HPLC & HPLC-MS), NMR	Adverse event	Passed Test
Colistimethate	Generic	For Injection	JHP Pharmaceuticals	Assay	Assess potency accuracy	Passed Test
Colistimethate	Generic	For Injection	X-Gen Pharmaceuticals	Assay	Assess potency accuracy	Passed Test
Cyclosporine (Restasis® )	RESTASIS (RLD)	Ophthalmic Emulsion	Allergan	Globule size distribution and zeta potential of various lots to determine variability of RLD	Comparative clinical endpoint study	Passed Test
Deoxycholic acid	KYBELLA (RLD)	Injection Solution	Kythera Biopharmaceuticals Inc.	ID, assay and impurities	Assess market quality	Passed Test
Doxorubicin HCl Liposome	DOXIL (RLD)	Injection	Janssen	Total Sulfate, Histidine (LC-MS), and ammonium sulfate (SAX)	Comparative study	Passed Test
Doxorubicin HCl Liposome	Generic	Injection	Sun Pharmaceuticals	Total Sulfate, Histidine (LC-MS), and ammonium sulfate (SAX)	Comparative study	Passed Test
Doxycycline Hyclate	Generic	Capsules	West-Ward Pharmaceuticals	Assay and Impurities Testing (USP)	Assess market quality	Passed Test
Heparin Sodium	Generic	IV Solution	B. Braun Medical Inc.	USP potency (anti-factor IIa) testing, strong anion exchange high performance liquid chromatography (SAX-HPLC), and 1D proton nuclear magnetic resonance (NMR)	Adverse event	Passed Test
Hydralazine HCl	Generic	Tablets	Hetero Drugs Limited	Dissolution, Impurities, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Hydralazine HCl	Generic	Tablets	Teva Czech Industries s.r.o.	Dissolution, Impurities, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Hydrocodone Bitartrate and Acetaminophen	Generic	Tablets	Sun Pharmaceuticals	Dissolution	Consumer complaint: lack of efficacy	Passed Test
Hydrocodone Bitartrate and Acetaminophen	Generic	Tablets	Mallinckrodt, Inc.	Dissolution	Consumer complaint: lack of efficacy	Passed Test
Hydrocodone Bitartrate and Acetaminophen	Generic	Tablets	Mallinckrodt Inc.	Assay, Dissolution, ID, Related Compounds, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Calfactant	INFASURF (RLD)	Intratracheal Suspension	Ony, Inc.	Test clogging of the tubes under required conditions as well as other experimental conditions to determine cause of clog, particle sizing	Adverse Event	Passed Test
Levetiracetam	Generic	Extended Release Tablets	Teva Pharma	Dissolution	Consumer Complaints	Passed Test
Lidocaine	Generic	Transdermal	Actavis, Inc.	90° peel adhesion to stainless steel, shear adhesion and tack, cold flow	Consumer complaints	Cold Flow Failed, all others Passed
Metformin HCl	Generic	Extended Release Tablets	Amneal Pharmaceuticals	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Extended Release Tablets	Apotex Inc.	Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Extended Release Tablets	Inventia Healthcare Private Ltd	Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Extended Release Tablets	Mylan Laboratories Limited	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Extended Release Tablets	Sun Pharmaceutical Industries	Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Extended Release Tablets	Teva Generics	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Tablets	Alkem Laboratories Ltd	Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Tablets	Amneal Pharmaceuticals	Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Tablets	Blu Caribe Inc.	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Tablets	Emcure Pharmaceuticals Limited	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Tablets	Glenmark Generics Ltd	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed test
Metformin HCl	Generic	Tablets	Granules India Limited	Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metformin HCl	Generic	Tablets	Sun Pharmaceutical Industries	Assay, Dissolution, ID, Related Compounds, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metoprolol Succinate	Generic	Extended Release Tablets	Dr. Reddy's Laboratories Ltd	Assay, Impurities, Dissolution, CU	Assess market quality	Passed Test
Metoprolol Tartrate	Generic	Tablets	Emcure Pharmaceuticals Limited	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Metoprolol Tartrate	Generic	Tablets	Ipca Laboratories Limited	Assay, Dissolution, ID, CU, WV, Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Niacin / Simvastatin	SIMCOR (brand)	Extended Release Tablets	Abbvie Inc.	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Pravastatin Sodium	Generic	Tablets	Apotex	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Pravastatin Sodium	Generic	Tablets	Glenmark Generics Ltd	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Pravastatin Sodium	Generic	Tablets	Teva Czech Industries	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Propafenone HCl	RYTHMOL (brand)	Tablets	Halo Pharmaceuticals	Assay, Dissolution, ID, Related Compounds, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Propafenone HCl	Generic	Tablets	Vintage Pharm (Qualitest Pharmaceuticals)	Assay, Dissolution, ID, Related Compounds, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Propranolol HCl	Generic	Tablets	Teva Czech Industries	Assay, Dissolution , CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Propranolol HCl and Hydrochlorothiazide	Generic	Tablets	Mylan Pharmaceuticals Inc.	Assay, Dissolution, ID, Related Compounds, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Rituximab	RITUXAN (RLD)	Injection	Genentech	Induction of apoptosis using flow cytometry and two cellular stains	Assess market quality	Passed Test
Simvastatin	Generic	Tablets	Blu Caribe Inc.	Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Simvastatin	Generic	Tablets	Lupin Limited	Dissolution, CU, WV, & Physical Attributes	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Simvastatin	Generic	Tablets	Teva Czech Industries	Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Tacrolimus	PROGRAF (brand)	Capsules	Astellas Pharma US, Inc.	Assay, Impurities and Dissolution	Assess market quality	Passed Test
Tacrolimus	Generic	Capsules	Sandoz	Assay, Impurities and Dissolution	Assess market quality	Passed Assay and Impurities; Failed Dissolution
Tacrolimus	Generic	Capsules	Dr. Reddy's Laboratories Ltd	Assay, Impurities and Dissolution	Assess market quality	Passed Test
Valsartan	DIOVAN (RLD)	Tablet	Novartis Pharmaceuticals Corporation	Assay, Dissolution, Raman Comparison	Consumer complaint	Passed Test
Valsartan	Generic	Tablet	Teva	Assay, Dissolution, Raman Comparison	Consumer complaint	Passed Test
Valsartan	Generic	Tablet	Ohm Laboratories Inc.	Assay, Dissolution, Raman Comparison	Consumer complaint	Passed Test
Venlafaxine HCl	Generic	Tablets	Dr. Reddy's Laboratories Ltd	Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Venlafaxine HCl	Generic	Tablets	Teva Pharm Industries	Dissolution, CU, WV	Compare high risk solid oral generic products made by India and non-India firms	Passed Test
Verapamil HCI	CALAN (RLD)	Tablets	G.D. Searle LLC Division of Pfizer Inc.	Dissolution	Assess market quality	Passed Test
Warfarin Sodium	Generic	Tablets	Taro Pharmaceuticals U.S.A., Inc.	IPA Content (GC), Dissolution	Adverse event report	Failed Test
Warfarin Sodium	COUMADIN (brand)	Tablets	Bristol-Myers Squibb	IPA Content (GC), Dissolution	Adverse event report	Passed Test
Warfarin Sodium	Generic	Tablets	Invagen Pharmaceuticals	IPA Content (GC), Dissolution	Adverse event report	Passed Test
Warfarin Sodium	Generic	Tablets	Zydus Pharmaceuticals	IPA Content (GC), Dissolution	Adverse event report	Passed Test

FY 14 Results

FY14 Drugs (PDF - 104KB)

FY14 Active Pharmaceutical Ingredient (PDF - 90KB)

Drug Quality: Postmarket Sampling and Testing Results (FY 2014)

Test results updated bi-annually.

Drug Name	Trade Name	Dosage Form	Firm	Tests Performed	Why Tested	Results
0.9% Sodium Chloride	Generic	Injection	Fresenius Medical Care	Microbiologic (bacterial endotoxin & visual exam; assay, identification (ID) and pH)	Reports of cloudiness	Passed Test
1.5% Dextrose Peritoneal Dialysis Solution	Delflex	Injection	Fresenius Medical Care	Microbiologic (bacterial endotoxin & visual exam; assay, ID and pH)	Reports of cloudiness and discoloration	Passed Test
5% Dextrose Injection USP Mini Bag Plus	Generic	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed Test
Albuterol Sulfate	Generic	Inhalation Aerosol	Teva Pharmaceuticals	Dose Uniformity	Product was found not to meet specifications during a research study	Passed Test
Amino Acid	Premasol	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed Test
Amino Acid	Travasol	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed Test
Amino Acid	Clinisol	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed Test
Amino Acid	Clinimix	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed Test
Amino Acid	ProSol	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed Test
Amino Acid	Clinimix E	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed Test
Amino acid with electrolytes	Generic	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin )	Reports of particulates and discoloration and closure defects/leaks	Passed Test
Amoxicillin	Generic	Tablets	Hikma Pharmaceuticals	Assay and impurities	Consumer adverse event complaint	Passed Test
Atorvastatin Calcium	Lipitor	Tablets	Parke-Davis Division of Pfizer Inc.	Dissolution, liquid chromatography-mass spectrometry (LC-MS)	Reports of Impurities	Passed Test
Atorvastatin Calcium	Generic	Tablets	Apotex Corp.	Dissolution, LC-MS	Reports of Impurities	Passed Test
Atorvastatin Calcium	Generic	Tablets	Greenstone	Dissolution, LC-MS	Reports of Impurities	Passed Test
Atorvastatin Calcium	Generic	Tablets	Kremers Urban Pharmaceuticals Inc Kremer	Dissolution, LC-MS	Reports of Impurities	Passed Test
Atorvastatin Calcium	Generic	Tablets	Mylan Pharmaceuticals Inc.	Dissolution, LC-MS	Reports of Impurities	Passed Test
Atorvastatin Calcium	Generic	Tablets	Ranbaxy Pharmaceuticals Inc	Dissolution, LC-MS	Reports of Impurities	Passed Test
Atorvastatin Calcium	Generic	Tablets	Dr. Reddy’s Laboratories Limited	Dissolution, LC-MS	Reports of Impurities	Passed Test
Atorvastatin Calcium	Generic	Tablets	Sandoz Inc.	Dissolution, LC-MS	Reports of Impurities	Passed Test
Bupropion XL	Wellbutrin XL	Tablets	Valeant Pharmaceuticals	Dissolution, assay and impurities	Verify drug quality for a clinical trial	Passed Test
Bupropion XL	Generic	Tablets	Watson Labs	Dissolution, assay and impurities	Verify drug quality for a clinical trial	Passed Test
Bupropion XL	Generic	Tablets	Anchen/Par Pharmaceuticals	Dissolution, assay and impurities	Verify drug quality for a clinical trial	Passed Test
Ciprofloxacin	Generic	Tablets	Dr. Reddy’s Laboratories Limited	Assay, dissolution, ID, weight variation	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Clopidogrel	Generic	Tablets	Dr. Reddy’s Laboratories Limited	Dissolution, assay and impurities	Consumer complaint	Passed Tests
Decitabine	Generic	For Injection	Dr. Reddy’s Laboratories Limited	Microbiologic (bacterial endotoxin)	Recent GMP violations and quality issues sdiscoloration and unknown impurities	Passed Tests
Dobutamine HCl in 5% Dextrose	Generic	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed test
Dopamine HCl and 5% Dextrose	Generic	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed Test
Fentanyl	Generic	Transdermal System	Mylan Pharmaceuticals Inc.	Assay, content uniformity, and degradation	Difficult to manufacture; past history violations; stability failure	Passed Tests
Fluconazole USP	Generic	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed Test
Fluoxetine	Generic	Capsules	Dr. Reddy’s Laboratories Limited	Content uniformity, dissolution, chromatographic purity, ID	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Gabapentin	Gralise	Tablets	Depomed, Inc.	Assay, content uniformity, dissolution, ID, related compounds	Atypical dissolution concerns	Passed Tests
Gentamicin Sulfate in 0.9% Sodium Chloride	Generic	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed Test
Glimepiride	Generic	Tablets	Dr. Reddy’s Laboratories Limited	Assay, content uniformity, dissolution, related substances, ID	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Heparin Sodium	Generic	Injection	Gland	Contamination	Large percentage of crude, API and finished dose heparin products are tested for contamination as a result of the 2008 heparin crisis	Passed Test
Heparin Sodium	Generic	Injection	Aurobindo	Contamination	Large percentage of crude, API and finished dose heparin products are tested for contamination as a result of the 2008 heparin crisis	Passed Test
Heparin Sodium	Generic	Injection	Hospira	Contamination	Large percentage of crude, API and finished dose heparin products are tested for contamination as a result of the 2008 heparin crisis	Passed Test
Heparin Sodium and 0.9% Sodium Chloride	Generic	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed Test
Lamotrigine	Generic	Extended Release Tablets	Dr. Reddy’s Laboratories Limited	Content uniformity, dissolution, related substances, ID, weight variation	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Lansoprazole	Generic	Delayed Release Capsules	Dr. Reddy’s Laboratories Limited	Content uniformity, dissolution, related substances, ID, weight variation	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Levothyroxine Sodium	Generic and Trade (Unithroid)	Tablets	Jerome Stevens	Assay, content uniformity, dissolution, impurities, weight variation, & ID	Field Alert and recalls of out-of-specification subpotency results, degradation, discoloration and foreign material complaints	Passed Test
Levothyroxine Sodium	Generic	Tablets	Mylan Pharmaceuticals Inc.	Assay, content uniformity, dissolution, impurities, weight variation, & ID	Field Alert and recalls of out-of-specification subpotency results, degradation, discoloration and foreign material complaints	Passed Test
Levothyroxine Sodium	Tirosint	Capsules	Institut Biochimique Sa, Lugano, Switzerland	Assay, content uniformity, dissolution, impurities, weight variation, & ID	Field Alert and recalls of out-of-specification subpotency results, degradation, discoloration and foreign material complaints	Passed Test
Levothyroxine Sodium	Levoxyl	Tablets	King Legacy (subsidiary of Pfizer)	Assay, content uniformity, dissolution, impurities, weight variation, & ID	Field Alert and recalls of out-of-specification subpotency results, degradation, discoloration and foreign material complaints	Passed Test
Levothyroxine Sodium	Synthroid	Tablets	Knoll LLC/dba Abbott Labs	Assay, content uniformity, dissolution, impurities, weight variation, & ID	Field Alert and recalls of out-of-specification subpotency results, degradation, discoloration and foreign material complaints	Passed Test
Levothyroxine Sodium	Generic	Tablets	Patheon Inc	Assay, content uniformity, dissolution, ID, impurities, poison/toxin screening	Atypical dissolution concerns	Passed Tests
Lidocaine HCl & 5% Dextrose	Generic	Injection	Baxter Healthcare Corp	Sterility & bacterial endotoxin & visual inspection of particulates and container defects	Reports of particulates and discoloration and closure defects/leaks	Passed Test
Loperamide HCl	Imodium A-D	Caplets	Janssen Ortho LLC	Assay, content uniformity, dissolution, ID degradation	Atypical dissolution concerns	Passed Tests
Methotrexate	Generic	Tablets	Mylan Technologies	Assay, content uniformity, dissolution, ID, water content, impurities	Generic product did not seem to work as effectively as trade product	Passed Tests
Methotrexate Sodium	Generic	Tablets	Mylan LLC	Assay, content uniformity, dissolution, impurities & ID	Complaints that generic product does not work as effectively as trade name product	Passed Test
Metronidazole USP	Generic	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed Test
Milrinone Lactate & 5% Dextrose	Generic	Injection	Baxter Healthcare Corp	Sterility & bacterial endotoxin & visual inspection of particulates and container defects	Reports of particulates and discoloration and closure defects/leaks	Passed Test
Montelukast Sodium	Generic	Tablets	Dr. Reddy’s Laboratories Limited	Content uniformity, dissolution, related substances, ID	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Montelukast Sodium	Generic	Oral Granules	Dr. Reddy’s Laboratories Limited	Content uniformity, dissolution, related substances, ID	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Nateglinide	Generic	Tablets	Dr. Reddy’s Laboratories Limited	Uniformity of dosage units, dissolution, impurities, ID	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Nitazoxanide	Alinia	For Oral Suspension	Patheon Inc	Assay, ID, viscosity, physical appearance	Viscosity and assay out-of-specification results during stability testing	Passed Tests
Nizatidine	Generic	Capsules	Dr. Reddy’s Laboratories Limited	Assay, dissolution ID, related substances	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Olanzapine	Generic	Tablets	Dr. Reddy’s Laboratories Limited	Content uniformity, dissolution, organic impurities, ID, weight variation	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Olanzapine	Generic	Orally disintegrating tablets	Dr. Reddy’s Laboratories Limited	Content uniformity, dissolution, related substances, ID, weight variation	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Potassium Chloride	Generic	Injection	Baxter Healthcare Corp	Microbiologic (bacterial endotoxin)	Reports of particulates and discoloration	Passed Test
Quetiapine Fumarate	Generic	Tablets	Dr. Reddy’s Laboratories Limited	Assay, content uniformity, dissolution, related substances, ID	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Ranitidine Hydrochloride	Generic	Capsules	Dr. Reddy’s Laboratories Limited	Assay, content uniformity, dissolution, ID, related substances	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Ropinirole	Generic	Extended Release Tablets	Dr. Reddy’s Laboratories Limited	Content uniformity, dissolution, related substances	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Sildenafil	Generic	Tablets	Dr. Reddy’s Laboratories Limited	Assay, dissolution, weight variation, uniformity of dosage units, organic impurities, ID	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Sumatriptan Succinate	Generic	Tablets	Dr. Reddy’s Laboratories Limited	Content uniformity, dissolution, related substances, ID	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Tacrolimus	Generic	Capsules	Dr. Reddy’s Laboratories Limited	Content uniformity, dissolution, impurities	Recent GMP violations and quality issues such as discoloration and unknown impurities	Passed Tests
Temozolomide	Temodar	Capsules	MSD Internat'l GmbH	Assay, content uniformity, dissolution, ID, impurities, weight uniformity	Degradation and impurity out-of-specification results during stability testing	Passed Tests

FY 13 Results

FY13 Active Pharmaceutical Ingredient (PDF - 100KB)

Drug Quality: Postmarket Sampling and Testing Results (FY 2013)

Drug Name	Trade Name	Dosage Form	Firm	Tests Performed	Why Tested	Results
Acetaminophen/ Diphenhydramine HCl / Phenylephrine HCl OTC product	Flu Relief Therapy Night Time	Liquid	Aaron Industries Inc.	Microbiologic, assay and identification (ID)	Firm’s method not stability indicating & USP method not verified under actual conditions.	Meets Quality Standards
Albuterol Sulfate	ProAir HFA	Inhalation Aerosol	Teva Respiratory, LLC	Particle size distribution, unit dose uniformity (UDU)	Product tested during a research project did not meet product specs.	Meets Quality Standards
Alprazolam	Xanax	Tablets	Pharmacia & Upjohn Company Division of Pfizer Inc	Assay, Dissolution, ID	Recall in 2012 for stability failures.	Meets Quality Standards
Amlodipine Besylate	Generic	Tablets	Epic Pharma LLC	Assay, ID, UDU, Impurities	Good manufacturing Process (GMP) issues at specific firm.	Meets Quality Standards
Atorvastatin Calcium	Lipitor	Tablets	Parke-Davis Division of Pfizer Inc.	Assay, UDU, Dissolution, ID	Top selling drug.	Meets Quality Standards
Atorvastatin Calcium	Generic	Tablets	Ranbaxy Pharmaceuticals Inc.	Assay, UDU, Dissolution, ID	Firm Top selling drug	Meets Quality Standards
Atorvastatin Calcium	Generic	Tablets	Ranbaxy Pharmaceuticals Inc.	Dissolution	Physician complaint	Meets Quality Standards
Azathioprine	Generic	Tablets	Mylan Pharmaceuticals Inc.	UDU, Dissolution, ID	Process variability issues	Meets Quality Standards
Bismuth Subsalicylate OTC product	Peptic Relief Maximum Strength	Suspension	Aaron Industries Inc.,	Assay, ID, pH; Microbiologic (yeast, mold)	Firm’s method not stability indicating, and USP method not verified under actual conditions	Failed: finding resulted in an inspection in March 2014 Aaron Indus. is now P&L Development
Dextromethorphan Hydrobromide & Guaifenesin OTC product	Tussin Cough & Chest Congestion DM	Liquid	Aaron Industries, Inc.	Assay and impurities; Microbiologic (yeast, mold)	Firm’s method not stability indicating and USP method not verified under actual conditions	Failed: finding resulted in an inspection in March 2014 Aaron Indus. is now P&L Development
Diclofenac Sodium, Misoprostol	Arthrotec	Tablets	G.D. Searle LLC Division of Pfizer Inc,	Assay, UDU, Dissolution, ID	Firm has had CGMP issues (inadequate controls); failure to submit Field Alert Reports	Meets Quality Standards
Epinephrine	Epinephrine	Injection	International Medication Systems	Assay, Clarity, pH, and ID; Microbiologic (sterility)	Important drug (for emergency use) with relatively short shelf life	Meets Quality Standards
Epinephrine	EpiPen	Auto-Injector	Mylan Specialty L.P.	Declared active ingredient; Microbiologic Growth	Important drug (for emergency use) with relatively short shelf life	Meets Quality Standards
Epinephrine	EpiPen Jr	Auto-Injector	Mylan Specialty L.P.	Declared active ingredient; Microbiologic	Important drug (for emergency use) with relatively short shelf life	Meets Quality Standards
Epinephrine	Epinephrine Abboject Syringe	Injection	Hospira, Inc.,	Assay, ID, pH, Color, Clarity	Important drug (for emergency use) with relatively short shelf life	Meets Quality Standards
Estradiol	Vivelle Dot	Transdermal System	Novartis Pharmaceuticals	Assay and ID; Adhesion and Liner Release	MedWatch reports cause general concern about transdermal products - adhesion as well as assay	Meets Quality Standards
Estradiol	Climara	Transdermal System	Bayer HealthCare Pharmaceuticals Inc.	Assay and ID; Peel Adhesion	MedWatch reports cause general concern about transdermal products - adhesion as well as assay	Meets Quality Standards
Estradiol	Generic	Transdermal Patches	Mylan Pharmaceuticals Inc.	Assay and ID; Liner Release, Probe Tack, Adhesion to Steel	MedWatch reports cause general concern about transdermal products - adhesion as well as assay	Meets Quality Standards
Estradiol	Alora	Transdermal System	Watson Laboratories Inc,	Assay and ID; Liner Release, Probe Tack, Adhesion to Steel	MedWatch reports cause general concern about transdermal products - adhesion as well as assay	Meets Quality Standards
Estradiol/ Levonorgestrel	Climara Pro	Transdermal System	Bayer HealthCare Pharmaceuticals Inc.	Assay and ID; Liner release and Peel Adhesion	MedWatch reports cause general concern about transdermal products - adhesion as well as assay	Meets Quality Standards
Norelgestromin and Ethinyl Estradiol	Ortho Evra	Transdermal System	Janssen Pharmaceuticals, Inc.	Assay, UDU, and ID; Liner release and Peel Adhesion	MedWatch reports cause general concern about transdermal products - adhesion as well as assay	Meets Quality Standards
Fentanyl	Generic	Transdermal System	Mallinckrodt Inc.	Assay and ID; Adhesion and Peel Strength	MedWatch reports cause general concern about transdermal products - adhesion as well as assay	Meets Quality Standards
Fentanyl	Generic	Transdermal System	Actavis South Atlantic LLC	Assay and ID; Probe Tack, Shear Adhesion, Adhesion Peel Strength	MedWatch reports cause general concern about transdermal products - adhesion as well as assay	Meets Quality Standards
Fentanyl	Generic	Transdermal System	Mylan Pharmaceuticals Inc,	Assay and ID: Peel Strength from Steel and Liner Release	MedWatch reports cause general concern about transdermal products - adhesion as well as assay	Meets Quality Standards
Finasteride	Generic	Tablets	Mylan Pharmaceuticals Inc,	Assay, UDU, Dissolution	Process variability issues	Meets Quality Standards
Fluoxetine hydrochloride	Generic	Capsules	Aurobindo Pharma USA, Inc.	Dissolution, assay	Tested as part of a research project	Meets Quality Standards
Fluoxetine hydrochloride	Generic	Capsules	Sandoz Inc	Dissolution, assay	Tested as part of a research project	Meets Quality Standards
Fluoxetine hydrochloride	Generic	Capsules	Mylan Pharmaceuticals Inc.	Dissolution, assay	Tested as part of a research project	Meets Quality Standards
Furosemide	Generic	Tablets	Ranbaxy Pharmaceuticals Inc.	Dissolution, assay	Physician complaint	Meets Quality Standards
Gabapentin	Generic	Capsules	Amneal Pharmaceuticals	Assay, UDU and Dissolution	Complaint on missing units during manufacturing	Meets Quality Standards
Gentamicin Sulfate	Generic	In 0.9% Sodium Chloride Injection	Baxter Healthcare Corporation,	pH and ID	GMP issues	Meets Quality Standards
Heparin Sodium	Generic	Injection	Hospira Inc.	Contamination	Large percentage of crude, API and finished dose heparin products are tested for contamination as a result of the 2008 heparin crisis.	Meets Quality Standards
Chlorpheniramine Maleate, Ibuprofen, pseudoephedrine HCl) OTC product	Advil Allergy Sinus	Tablet	Pfizer	UDU, Dissolution, and ID	Process Variability issues	Meets Quality Standards
Ibuprofen OTC product	Advil	Tablet	Pfizer	Assay, UDU, Dissolution and ID	Process Variability issues	Meets Quality Standards
Lamivudine & Zidovudine	Combivir	Capsules	ViiV Healthcare	UDU, Dissolution and ID	GMP Issues with some manufacturers	Meets Quality Standards
Lamivudine & Zidovudine	Generic	Capsules	Teva Pharmaceuticals	Assay, UDU and Dissolution	Warning Letter 3/2010 re: drug contamination & GMP issues; not surveyed before	Meets Quality Standards
Lamivudine	Epivir	Tablets	ViiV Healthcare	Assay, UDU, Dissolution and ID	GMP Issues with some manufacturers	Meets Quality Standards
Lamivudine	Generic	Tablets	Apotex Corp.	Assay, ID, Impurities, and Dissolution	GMP Issues with some manufacturers	Meets Quality Standards
Lamivudine	Generic	Tablets	Aurobindo Pharma USA, Inc.	Assay, Dissolution, UDU and ID	GMP Issues with some manufacturers	Meets Quality Standards
Lenalidomide	Revlimid	Capsules	Celgene Corp.	Assay, UDU and Dissolution	Question post approval controls	Meets Quality Standards
Levothyroxine Sodium	Synthroid	Tablets	Abbvie Inc.	Assay	Physician Complaint	Meets Quality Standards
Levothyroxine Sodium	Generic	Tablets	Alara Pharmaceutical Corporation	Assay	Physician Complaint	Meets Quality Standards
Levothyroxine Sodium	Generic	Tablets	Lannett Company, Inc.	Assay	Physician Complaint	Meets Quality Standards
Levothyroxine Sodium	Generic	Tablets	Mylan Pharmaceuticals Inc.	Assay	Physician Complaint	Meets Quality Standards
Losartan Potassium	Generic	Tablets	Torrent Pharma Inc.	Assay, ID and Impurities	Check assay, impurities, and dissolution. Warning Letter May 2011 re: GMP issues; not surveyed before; widely prescribed;	Meets Quality Standards
Losartan Potassium	Generic	Tablets	Aurobindo Pharma USA, Inc.	Assay, Dissolution, UDU	Consumer Complaint	Meets Quality Standards
Losartan Potassium & Hydrochlorothiazide	Generic	Tablets	Aurobindo Pharma USA, Inc..	Assay, UDU, Dissolution and ID	Check assay, impurities, and dissolution. Warning Letter May 2011 re: GMP issues;	Meets Quality Standards
Methyphenidate	Daytrana	Transdermal System	Noven Therapeutics, LLC	Assay and ID; Shear and Peel Liner Release	MedWatch reports cause general concern about transdermal products - adhesion as well as assay	Meets Quality Standards
Metoprolol Succinate	Toprol XL	Extended Release Tablets	AstraZeneca LP	Dissolution	Physician complaint	Meets Quality Standards
Metoprolol Succinate	Generic	Extended Release Tablets	Dr. Reddy’s Laboratories Limited	Dissolution	Physician complaint	Meets Quality Standards
Metoprolol Succinate	Generic	Extended Release Tablets	Par Pharmaceutical Inc.	Dissolution	Physician complaint	Meets Quality Standards
Metoprolol Succinate	Generic	Extended Release Tablets	Mylan Pharmaceuticals Inc.	Dissolution	Physician complaint	Meets Quality Standards
Metoprolol Succinate	Generic	Extended Release Tablets	Wockhardt USA LLC.	Dissolution	Physician complaint	Meets Quality Standards
Metoprolol Succinate	Generic	Extended Release Tablets	Watson Pharma, Inc.	Dissolution	Physician complaint	Meets Quality Standards
Metoprolol Tartrate	Generic	Extended Release Tablets	Ranbaxy Pharmaceuticals Inc.	Dissolution	Physician complaint	Meets Quality Standards
Olanzapine	Generic	Tablets	Dr. Reddy’s Laboratories Limited	UDU, Dissolution and ID	Top selling drug;	Meets Quality Standards
Oxycodone HCl	Generic	Tablets	Caraco Pharmaceutical Laboratories, Ltd.	Assay, UDU and ID Dissolution	Complaints questioning potency	Meets Quality Standards
Oxybutynin	Oxytrol	Transdermal System	Actavis	Assay, ID, adhesion	MedWatch reports cause general concern about transdermal products - adhesion as well as assay	Meets Quality Standards
Protamine Sulfate	Generic	Injection	APP Pharmaceuticals LLC,	Assay, impurities	Response to adverse events	Meets Quality Standards
Tacrolimus	Generic	Capsules	Mylan Pharmaceuticals Inc.	Assay, Crystallinity, Dissolution, ID	Process validation issues	Meets Quality Standards
Temozolomide	Temodar	Capsules	Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC.,	Assay, UDU, Dissolution and ID	Process variability issues	Meets Quality Standards
Torsemide	Generic	Tablets	Teva Pharm	Dissolution, Assay	Physician complaint	Meets Quality Standards
Valacyclovir HCl	Generic	Tablets	Aurobindo Pharma USA, Inc.	Assay, UDU, Dissolution and ID	GMP issues: survey of several manufacturers was performed	Meets Quality Standards
Venlafaxine HCl	Generic	Extended Release Capsules	Aurobindo Pharma USA, Inc.	Assay, UDU, Dissolution and ID	GMP issues: survey of several manufacturers was performed	Meets Quality Standards
Venlafaxine HCl	Generic	Extended Release Tablets	Kremers Urban	Assay, UDU, Dissolution, ID and Related Compounds	GMP issues: survey of several manufacturers was performed	Meets Quality Standards
Venlafaxine HCl	Generic	Extended Release Capsules	Wockhardt USA LLC	Assay, UDU, Dissolution and ID	GMP issues: survey of several manufacturers was performed	Meets Quality Standards
Warfarin Sodium	Coumadin	Tablets	Bristol-Myers Squibb Company	UDU, Dissolution and ID	Past recalls raise concerns that product may not conform to shelf life	Meets Quality Standards
Zolpidem Tartrate	Generic	Tablets	Torrent Pharma Inc.	Assay and ID	Missing units from manufacturing	Meets Quality Standards

Additional Resources

Contact Us

How to Contact FDA

Division of Drug Information

For general drug-related questions:

Telephone: 855-543-3784 or 301-796-3400
Email: [email protected]

Alerting FDA to Potential Safety or Quality Issues

If you are concerned about a drug product or have experienced an adverse event from a medication, please tell your health care professional. Health care professionals and consumers are encouraged to report adverse events or quality problems experienced with the use of a product to FDA's MedWatch Safety Information and Adverse Event Reporting program:

Complete and submit the report online at www.fda.gov/medwatch/report.htm
Download and complete the form, then submit it via fax at 1-800-FDA-0178

FDA uses these reports to track potential public health risks and compare our scientific data with the information we receive to determine if further actions and analyses are necessary.

Request Information through FDA's Freedom of Information Office

If you cannot find the information you are looking for using FDA’s search function, you can make an information request under the U.S. Freedom of Information Act (FOIA). Such documents are not prepared specifically for public distribution, but are available upon specific written request. For more information: