Drug product
Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack
D-0171-2025
Product summary
- Event
- Event 95930
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 23304 packs
- Official record key
drug-enforcement:D-0171-2025
Official wording
Reason: Crystallization
Code information: Lots T400513, Exp Date 02/2026; T400807, Exp Date 03/2026; T401152, Exp Date 06/2026; T401303, Exp Date 07/2026; T401304, Exp Date 07/2026; T401399, Exp Date 07/2026 & T401696 Exp Date 08/2026.
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
Crystallization