Class II · Moderate risk Terminated
Valsartan
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Valsartan HCTZ
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Indomethacin Capsules
Reason Failed Tablet/Capsule Specifications: customer complaints of deformed, clumped, misshaped, melted or stuck together capsules.
Class II · Moderate risk Terminated
Potassium Citrate Extended-Release Tablets
Reason Failed Tablet/Capsule Specifications: Tablet breakage
Class II · Moderate risk Terminated
Potassium Citrate Extended-Release Tablets
Reason Failed Tablet/Capsule Specifications: Tablet breakage
Class II · Moderate risk Terminated
Unit Dose Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Unit Dose Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Eyewash Purified water 98.3%
Reason CGMP Deviations
Class II · Moderate risk Terminated
Emergency First Aid Eyewash
Reason CGMP Deviations
Class II · Moderate risk Terminated
Valsartan/HCTZ 320mg/12.5 mg tablet
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Valsartan/HCTZ 160 mg/12.5 mg tablet
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class II · Moderate risk Terminated
Omega-3-Acid Ethyl Esters Capsules USP
Reason API material used in the manufacturing of the product did not receive regulatory approval prior to release.
Class II · Moderate risk Terminated
Testosterone Cypionate Injection
Reason Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
Class II · Moderate risk Terminated
alba BOTANICA sport mineral sunscreen
Reason Incorrect Product Formulation: wrong sunscreen product in the package.
Class II · Moderate risk Terminated
Fluocinolone Acetonide Topical Solution
Reason 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 Terminated
Metformin Hydrochloride Extended Release Tablets
Reason 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 Terminated
Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL
Reason CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.
Class II · Moderate risk Terminated
Monsel's Solution
Reason CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
Class II · Moderate risk Terminated
Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use
Reason Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding.
Class II · Moderate risk Terminated
Daptomycin for Injection
Reason Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.
Class II · Moderate risk Terminated
Nitrofurantoin Oral Suspension USP
Reason Subpotent Drug and Failed Content Uniformity.
Class II · Moderate risk Terminated
Glutathione 200mg/mL Injection w/Pres.
Reason 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 Terminated
Methyl Folate CA+ 1mg/ml Injection w/Pres.
Reason 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 Terminated
Methylcobalamin 1mg/mL Injection w/Pres.
Reason Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.