Losartan Potassium Tablets USP 50 mg
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
14,450 recalls · Class II, newest first
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
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Reason CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Reason CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs
Reason CGMP Deviations: These products have been found to be misbranded as unapproved new drugs