Drug product
Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd., Changodar Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016. NDC: 72578-102-04
D-0595-2025
Product summary
- Event
- Event 97424
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3960 bottles
- Official record key
drug-enforcement:D-0595-2025
Official wording
Reason: Discoloration
Code information: Lot #: T401968
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Unknown
Discoloration