ChlorproMAZINE Hydrochloride Tablets recall — Class II (D-0366-2025) · pharmaranks
Class IIOngoing
ChlorproMAZINE Hydrochloride Tablets recall
FDA recall D-0366-2025 · initiated Apr 14, 2025
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Details
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
Recalling company
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
Nationwide USA
Initiated
Apr 14, 2025
FDA report date
Apr 23, 2025
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.