FDAHealthApril 14, 2025
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distri
⚠️ CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- April 14, 2025
Nationwide USA
What's affected?
- Product
- 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
- Lot code
- N02114
Additional details
Lot#: N02114, Exp 12/31/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 133 cartons.
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