Prescription and over-the-counter medications
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
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Legacy Pharmaceutical Packaging
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Lack of Assurance of Sterility
Lack of Assurance of Sterility
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
Lack of Assurance of Sterility
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.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility