💊 Drugs • 11,927 recalls
Ingenus Pharmaceuticals
Defective Container: firm discovered samples stored horizontally as well as product quality complaints from customers for bottles leaking.
cGMP Deviations
Defective Container: Repetitive complaints received indicating pump not working.
Iso-Tex Diagnostics
Lack of Assurance of Sterility: preliminary environmental monitoring report exceeds limits, therefore sterility cannot be assured.
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
American Health Packaging
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Legacy Pharmaceutical Packaging
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Legacy Pharmaceutical Packaging
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Rising Pharmaceuticals
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
Lack of Assurance of Sterility
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
Rising Pharmaceuticals
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Aurobindo Pharma USA
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Aurobindo Pharma USA
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Heritage Pharmaceuticals
Subpotent Drug.