ChlorproMAZINE Hydrochloride Tablets recalled over manufacturing violations
- Recall date
- April 14, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and…
- Recall number
- D-0366-2025
- FDA classification
- Class II
- Brand / firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Sold / distributed
- Nationwide USA
Why it was recalled
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61
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