Home / Recalls / Glenmark Pharmaceuticals Inc., USA / D-0621-2024

D-0621-2024 Class II Ongoing

Recalled by Glenmark Pharmaceuticals Inc., USA — Mahwah, NJ

Recall Details

Product Type
Drugs
Report Date
August 7, 2024
Initiation Date
July 22, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
14,004 cartons

Product Description

Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa, 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-626-52.

Reason for Recall

CGMP Deviations

Distribution Pattern

U.S. Nationwide

Code Information

Lot# 19241453; Exp MARCH 2026

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  • D-0662-2025 Class II — Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: (September 17, 2025)
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  • D-0578-2025 Class II — Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Gl (August 7, 2025)
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