676 recalls · Class II, newest first
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 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.
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Reason Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Reason Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Reason Presence of Foreign Tablets/Capsules.
Reason Failed Dissolution Specifications - low dissolution results
Reason Chemical Contamination: Presence of benzene.
Reason Lack of Assurance of Sterility: due to a quality control process deviation
Reason Subpotent Drug
Reason Subpotent Drug
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.