Recall
FDAHealthMarch 13, 2025

Glenmark Pharmaceuticals Inc., USA — Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Ma

⚠️ CGMP Deviations

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
March 13, 2025

U.S. Nationwide

What's affected?

Product
Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-338-01
UPC
0368462338018
Lot code
17232206

Additional details

Lot # 17232206, exp. date Sep-25

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: N/A.

View original FDA notice →

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