Why it was recalled
CGMP Deviations
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.
Lot numbers, UPCs & expiration codes
Lot# 19241453; Exp MARCH 2026
Where it was sold
U.S. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0621-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 22, 2024
- FDA report date
- Aug 7, 2024
- Quantity
- 14,004 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-0621-2024, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 95022
- Address
- 750 Corporate Dr
- Code information
- Lot# 19241453; Exp MARCH 2026
- Postal code
- 07430-2009
- Report date
- Aug 7, 2024
- Product type
- Drugs
- Recall number
- D-0621-2024
- Classification
- Class II
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Product quantity
- 14,004 cartons
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Jul 22, 2024
- Initial firm notification
- Letter
- Center classification date
- Jul 29, 2024