Drug 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.
D-0621-2024
Product summary
- Event
- Event 95022
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 14,004 cartons
- Official record key
drug-enforcement:D-0621-2024
Official wording
Reason: CGMP Deviations
Code information: Lot# 19241453; Exp MARCH 2026
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations