D-0662-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- October 1, 2025
- Initiation Date
- September 17, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13824 tubes
Product Description
Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, 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: Market complaints received for gritty texture (grainy)
Distribution Pattern
Nationwide within the United States
Code Information
Batch # 19252524, Exp Date: May 2027