FDA Recall D-0621-2024
Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ
Class II Ongoing 661 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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.
Reason for recall
CGMP Deviations
Recall record
- Recall number
D-0621-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- U.S. Nationwide
- Recall initiated
- 2024-07-22
- Classified by FDA Center
- 2024-07-29
- FDA published
- 2024-08-07
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Firm location
- Mahwah, NJ
Drug identification
- Brand name(s)
- AZELAIC ACID
- Generic name(s)
- AZELAIC ACID
- Manufacturer(s)
- Glenmark Pharmaceuticals Inc., USA
- NDC(s)
68462-626- Route(s)
- TOPICAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.