Drug 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
D-0662-2025
Product summary
- Event
- Event 97619
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 13824 tubes
- Official record key
drug-enforcement:D-0662-2025
Official wording
Reason: CGMP Deviations: Market complaints received for gritty texture (grainy)
Code information: Batch # 19252524, Exp Date: May 2027
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations