Class II · Moderate risk
Meropenem for Injection
Lack of assurance of sterility: loss of container integrity.
FDA Drug Recalls
11,818 recalls · Class II, newest first
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
Class II · Moderate risk
Trimix ST-1 30PA-1.5PH-50A Aqueous Solution Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix Papaverine/Phentolamine/Alprostadil/Lidocaine 30 mg/1…
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/60 mcg Powder Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/20 mcg Powder Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/10 mcg Powder Pharm D Solutions
Lack of Assurance of Sterility
Class II · Moderate risk
Trimix AT-6 Papa 30 mg/Phent 4 mg/Atrop. 0.3 mg Injectable
Lack of Assurance of Sterility