FDAHealthMarch 13, 2025

Glenmark Pharmaceuticals Inc., USA — Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Man

⚠️ 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: Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-433-18
Brand: COLESEVELAM HYDROCHLORIDE
UPC: 0368462433188
Lot code: 17240669

Additional details

Lot # 17240669, exp. date Mar-26 17240876, exp. date Apr-26 17240883, exp. date May-26 17240909, exp. date May-26 17240914, exp. date May-26 17240927, exp. date May-26

What should I do?

Recommended action

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

View original FDA notice →

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