💊 Drugs • 12,141 recalls
Perrigo New York
Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
Failed dissolution specifications
Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Dr. Reddy's Laboratories
Failed Dissolution Specifications: Out of specification results observed for high dissolution.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
Labeling: Incorrect expiration date.
CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
ACP Nimble Buyer
Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.
Lack of assurance of sterility.
CGMP Deviations
Promise Pharmacy
Lack of sterility assurance.
Promise Pharmacy
Lack of sterility assurance.