17,898 recalls, newest first
Reason CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Reason CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Reason CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
Reason CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Reason CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Reason CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Reason CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Reason Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Reason Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh…
Reason Presence of foreign substance: identified as aluminum.
Reason Lack of Assurance of Sterility.
Reason Lack of Assurance of Sterility.
Reason Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Reason Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Reason Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.
Reason CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Reason CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Reason CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Reason Microbial Contamination of Sterile Products: elevated endotoxin levels
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 Lack of Assurance of Sterility