FDAHealthJuly 22, 2024
Glenmark Pharmaceuticals Inc., USA — Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa, 403513, India, Manufactured for: Glenm
⚠️ CGMP Deviations
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 22, 2024
U.S. Nationwide
What's affected?
- Product
- 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.
- Brand
- AZELAIC ACID
- UPC
- 0368462626528
- Lot code
- 19241453
Additional details
Lot# 19241453; Exp MARCH 2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 14,004 cartons.
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