US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jul 2, 2013 (13 years ago)

chlorproMAZINE HCl

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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.

What was recalled

chlorproMAZINE HCl, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00832030200.

Recalling firm
Aidapak Services, LLC
Origin
WA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1014-2014

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.

Other Chlorpromazine recalls

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Class II · Moderate risk Ongoing

Major ChlorproMAZINE Hydrochloride Tablets

Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-7133-61 D-0013-2026
Class II · Moderate risk Ongoing

Major ChlorproMAZINE Hydrochloride Tablets

Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-7132-61 D-0012-2026
Class II · Moderate risk Ongoing

Major ChlorproMAZINE Hydrochloride Tablets

Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-7131-61 D-0011-2026
Class II · Moderate risk Ongoing

Major ChlorproMAZINE Hydrochloride Tablets

Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-7130-61 D-0010-2026
Class II · Moderate risk Ongoing

Major ChlorproMAZINE Hydrochloride Tablets

Reason CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-7130-06 D-0009-2026