Drugs

Drug Quality Sampling and Testing Programs

 

Quality Sampling and Testing graphic

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 and through research contracts and grants. 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 testing is one way that FDA works to help ensure patients have access to safe, effective, quality drugs.

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 dozens of drug products each year based on certain criteria.

  • Some testing decisions are event-driven. 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. For example, results from independent research may require FDA testing and investigation.

Sometimes, manufacturing or facility concerns may trigger additional FDA monitoring and testing. For instance, FDA may sample products with difficult manufacturing processes or drug products with complex dosage forms such as 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 is likely to become contaminated with a harmful impurity during the manufacturing process, FDA tests for that specific impurity, rather than testing for all potential impurities.

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
Testing Standards and FDA Response to Substandard Outcomes

FDA's laboratories generally test drugs to standards set by the U.S. Pharmacopeia (USP) disclaimer icon, 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: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. 

  • 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.

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

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

FY13 Active Pharmaceutical Ingredient (PDF - 100KB)

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

Drug Name

Trade Name

Dosage Form

Firm

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

How to Contact FDA 

 

Division of Drug Information  

For general drug-related questions:

Telephone: 855-543-3784 or 301-796-3400
Email: druginfo@fda.hhs.gov 

 

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:

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:

 
 

 

 

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