FDAFDA · Food and drugs·Recall number D-0621-2024
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.
Published August 7, 2024 · Recall initiated: July 22, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- AZELAIC ACID
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Distributor
- U.S. Nationwide
- UPC
- 0368462626528
- Lot
- Lot# 19241453; Exp MARCH 2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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