Drug Quality Sampling and Testing Programs
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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 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
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.
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 |
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 |
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 | 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 |
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 / |
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 |
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 |
Dextromethorphan Hydrobromide & Guaifenesin |
Tussin |
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 |
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 |
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) |
Advil Allergy Sinus |
Tablet |
Pfizer |
UDU, Dissolution, and ID |
Process Variability issues |
Meets Quality Standards |
Ibuprofen |
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. |
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 |
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 |
|
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:
-
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: