17,898 recalls, newest first
Reason Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.
Reason GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Reason GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Reason GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Reason GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Reason GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Reason GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Reason Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle
Reason CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.
Reason Superpotent
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Reason CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Reason Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
Reason CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Reason CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Reason CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Reason Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
Reason Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million.
Reason Lack of sterility assurance.
Reason Microbial Contamination of Non-Sterile Product.
Reason cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the product, but rather were identified on the filling line.