Class II · Moderate risk
Tesamorelin
Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration date instead of a 6 month expiration date
FDA Drug Recalls
982 recalls · Class II, newest first
Class II · Moderate risk
Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial
Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing
Class II · Moderate risk
Prevacid 24HR
CGMP deviations
Class II · Moderate risk
Lidocaine 1% + Epinephrine 1:100
Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent.
Class II · Moderate risk
Nystatin and Triamcinolone Acetonide Cream
Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
Class II · Moderate risk
Clozapine Orally Disintegrating Tablets
Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
Class II · Moderate risk
Meropenem for Injection
Lack of assurance of sterility: loss of container integrity.
Class II · Moderate risk
Clonazepam Orally Disintegrating Tablets USP
Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.
Class II · Moderate risk
Glipizide XL
CGMP Deviations; rejected product was used to manufacture final bulk lot
Class II · Moderate risk
Bumetanide Tablets
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Class II · Moderate risk
Bumetanide Tablets
Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Class II · Moderate risk
Elelyso (taliglucerase alfa)
Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
Class II · Moderate risk
SparkleFresh Fluoride Toothpaste
Microbial Contamination of Non-Sterile Product
Class II · Moderate risk
Lamotrigine Extended-Release Tablets
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Class II · Moderate risk
Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone in Grapeseed Oil 200 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Zinc Sulfate 1 mg/mL MDV Injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Water Sterile for Injection 250 mL IV Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Vigamox Oph. Solution Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix T105 PGE/Phentolamine/Papaverine 10 mcg/30 mg/1 mg Injectable Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix T-106 30PA-1PH-25A Aqueous Solution Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix T-101 Alprostadil/Phapaverine/Phentolamine 5.9 mcg/17.65…
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix ST9D 30PA-2PH-150A Aqueous Solution Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Phentolamine 1 mg/Papaverine 15 mg/Alprostadil 150 mcg Aqueous Solution Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix ST-9B 30 PA-2PH-100A Aqueous Solution Pharm D Solutions
Lack of Assurance of Sterility