FDA Recall D-0366-2025

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · La Vergne, TN

Class II Ongoing 395 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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: Lot#: N02114, Exp 12/31/2025

Quantity: 133 cartons

Reason for recall

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

Recall record

Recall number: D-0366-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide USA
Recall initiated: 2025-04-14
Classified by FDA Center: 2025-04-16
FDA published: 2025-04-23
Recalling firm: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Firm location: La Vergne, TN

Drug identification

Brand name(s): CHLORPROMAZINE HYDROCHLORIDE
Generic name(s): CHLORPROMAZINE HYDROCHLORIDE
Manufacturer(s): Major Pharmaceuticals
NDC(s): 0904-7132, 0904-7129, 0904-7130, 0904-7131, 0904-7133
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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