Drug product
Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.
D-0011-2025
Product summary
- Event
- Event 95412
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2544 pumps
- Official record key
drug-enforcement:D-0011-2025
Official wording
Reason: Crystallization
Code information: Lot #: T400512, Exp 02/28/2026
Distribution pattern: NY
Derived failure modes
-
Unknown
Crystallization