chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals…
Reason CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
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Reason CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
Reason Chemical contamination: presence of benzene
Reason Chemical contamination: presence of benzene
Reason 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
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Reason Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
Reason Lack of Assurance of Sterility
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 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 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