676 recalls · Class II, newest first
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 abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.
Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.
Presence of foreign substance: Presence of Benzene.
Presence of foreign substance: Presence of Benzene.
Failed Dissolution Specifications
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
Chemical Contamination: Presence of benzene
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Stability data does not support expiry: the products have the potential to be out of specification at the time of expiry of 36-months.
Presence of Foreign Tablets/Capsules.
Failed Dissolution Specifications - low dissolution results
Chemical Contamination: Presence of benzene.
Lack of Assurance of Sterility: due to a quality control process deviation
Subpotent Drug
Subpotent Drug
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.