WhichRecall
Class IIReported 2025-10-15

Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7132-61, UPC (01)00309047132614

Recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Reason for Recall

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

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Recall Number
D-0012-2026
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-09-12
Reported
2025-10-15
Distribution
Nationwide
Code Info
Lots N01920, Exp. Date, 12/31/2025, N02023, Exp. Date, 02/28/2026 & N02202, Exp. Date, 06/30/2026
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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