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-0038-2025
Product summary
- Event
- Event 95650
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6048 pumps
- Official record key
drug-enforcement:D-0038-2025
Official wording
Reason: Crystallization
Code information: Lots T401151, Exp, 06/30/2026; T400806, Exp 03/31/2026
Distribution pattern: USA Nationwide
Derived failure modes
-
Unknown
Crystallization