FDARecalled Oct 1, 2025 · #D-0662-2025
Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India, Manufactured for: Glenmark Pharmaceuticals Inc.,...
Hazard
Class II — temporary health risk
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CGMP Deviations: Market complaints received for gritty texture (grainy) Classification: Class II Distribution: Nationwide within the United States
Product details
- Product
- Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, 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
- Type
- Drugs
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Model numbers
- —
- UPCs
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