Recalls / Class II
Class IID-0621-2024
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.
- Brand name
- Azelaic Acid
- Generic name
- Azelaic Acid
- Active ingredient
- Azelaic Acid
- Route
- Topical
- NDC
- 68462-626
- FDA application
- ANDA204637
- Affected lot / code info
- Lot# 19241453; Exp MARCH 2026
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 14,004 cartons
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2024-07-22
- FDA classified
- 2024-07-29
- Posted by FDA
- 2024-08-07
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0621-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.