💊 Drugs • 12,141 recalls
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.
Subpotent Drug.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.
Legacy Pharmaceutical Packaging
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
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
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.