WhichRecall
Class IIReported 2025-04-23

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

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

Reason for Recall

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

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Recall Number
D-0366-2025
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-04-14
Reported
2025-04-23
Distribution
Nationwide USA
Code Info
Lot#: N02114, Exp 12/31/2025
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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