Propafenone Hydrochloride Extended-Release Capsules 325mg
CGMP Deviations
Every FDA drug recall whose status is still Ongoing: the firm is still removing product from the market, or the FDA has not yet closed the file. Some were opened years ago and never formally terminated, so check the initiation date as well as the status.
2,760 recalls, newest first.
CGMP Deviations
CGMP Deviations
CGMP Deviations
cGMP deviations
cGMP deviations
cGMP deviations
cGMP deviations
Chemical contamination: Presence of benzene
Chemical contamination: Presence of benzene
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Chemical contamination: presence of benzene
Chemical contamination: presence of benzene
Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Lack of Assurance of Sterility
Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol
Super-Potent Drug: Out of specification potency results were obtained.
Super-Potent Drug: Out of specification potency results were obtained.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
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.
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.