💊 Drugs • 11,927 recalls
Avkare Incorporated
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Avkare Incorporated
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Avkare Incorporated
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity.
Avkare Incorporated
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Avkare Incorporated
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Supterpotent Drug
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.
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices contain the correct lot number of FG10517.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Baxter Healthcare
CGMP Deviations
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Validus Pharmaceuticals
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide