778 recalls, newest first
Reason Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol
Reason Super-Potent Drug: Out of specification potency results were obtained.
Reason Super-Potent Drug: Out of specification potency results were obtained.
Reason CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Reason CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an…
Reason cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an…
Reason Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.
Reason Presence of foreign substance: Presence of Benzene.
Reason Presence of foreign substance: Presence of Benzene.
Reason Failed Dissolution Specifications
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Reason Cross Contamination
Reason Cross Contamination
Reason Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Reason CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug…
Reason CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Reason CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Reason CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Reason CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Reason Chemical Contamination: Presence of benzene
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.