💊 Drugs • 11,927 recalls
Sun Pharmaceutical Industries
Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Aidarex Pharmaceuticals
Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
MAJOR PHARMACEUTICALS
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Avella of Deer Valley, Inc. Store 38
Lack of Assurance of Sterility: Potential leakage of bags.
La Vita Compounding Pharmacy
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
La Vita Compounding Pharmacy
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
La Vita Compounding Pharmacy
Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
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.
Mylan Pharmaceuticals
Subpotent Drug
Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding.
Wockhardt Limited
Failed Impurities/Degradation Specifications
AMERICAN HEALTH PACKAGING
Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
Wockhardt Limited
Failed Impurities/Degradation Specifications
Presence of Particulate Matter: identified as glass and silicone material
CGMP Deviations
Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
Subpotent Drug and Failed Content Uniformity.