Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 60 Tablets NDC…
Reason CGMP deviation: Product found to contain trace amounts of NMBA
Recalls of ARBs, ACE inhibitors, beta blockers and other hypertension drugs - the class behind the large valsartan and losartan nitrosamine recalls.
548 recalls in this category, newest first.
Reason CGMP deviation: Product found to contain trace amounts of NMBA
Reason CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Reason CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Reason CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Reason CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
Reason CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Reason CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Reason CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable…
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable…
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable…
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable…
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable…
Reason CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable…
Reason CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Reason CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Reason CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient
Reason Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
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