D-0621-2024 Class II Ongoing
FDA drug recall D-0621-2024 was initiated by Glenmark Pharmaceuticals Inc., USA on July 22, 2024 and is designated Class II. Reason for recall: CGMP Deviations The recall status is ongoing. Affected quantity: 14,004 cartons.
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