Drug product
Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless pump pack
D-0172-2025
Product summary
- Event
- Event 95930
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2760 packs
- Official record key
drug-enforcement:D-0172-2025
Official wording
Reason: Crystallization
Code information: Lots T400514, Exp Date 02/2026 & T400808, Exp Date 03/2026
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
Crystallization