Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: chlorproMAZINE HCl, Tablet, 50 mg may have potentially been mislabeled as the following drug: ACAMPROSATE CALCIUM DR, Tablet, 333 mg, NDC 00456333001, Pedigree: AD32973_1, EXP: 5/9/2014.
chlorproMAZINE HCl, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00832030200.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
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