Class II · Moderate risk
Valsartan and Hydrochlorothiazide
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
FDA Drug Recalls
982 recalls · Class II, newest first
Class II · Moderate risk
Solco Healthcare US Valsartan and Hydrochlorothiazide
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Solco Healthcare US Valsartan and Hydrochlorothiazide
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Solco Healthcare US Valsartan and Hydrochlorothiazide
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Solco Healthcare US Valsartan and Hydrochlorothiazide
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Solco Healthcare US Valsartan and Hydrochlorothiazide
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Solco Healthcare US Valsartan
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Solco Healthcare US Valsartan
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Solco Healthcare US Valsartan
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Solco Healthcare US Valsartan
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk
Testosterone Cypionate Injection
Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
Class II · Moderate risk
Admelog Solostar
Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
Class II · Moderate risk
alba BOTANICA sport mineral sunscreen
Incorrect Product Formulation: wrong sunscreen product in the package.
Class II · Moderate risk
Fluocinolone Acetonide Topical Solution
Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
Class II · Moderate risk
Metformin Hydrochloride Extended Release Tablets
Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet.
Class II · Moderate risk
Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL
CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.
Class II · Moderate risk
Monsel's Solution
CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
Class II · Moderate risk
Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use
Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding.
Class II · Moderate risk
Daptomycin for Injection
Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
Class II · Moderate risk
Nitrofurantoin Oral Suspension USP
Subpotent Drug and Failed Content Uniformity.
Class II · Moderate risk
Glutathione 200mg/mL Injection w/Pres.
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Class II · Moderate risk
Methyl Folate CA+ 1mg/ml Injection w/Pres.
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Class II · Moderate risk
Methylcobalamin 1mg/mL Injection w/Pres.
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Class II · Moderate risk
Acetylcysteine for Injection 6 g/30 mL
CGMP Deviations
Class II · Moderate risk
eb5 Skincare that Works. Age Spot Treatment. Skin Lightening…
Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity