Drug product
Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-102-04.
D-0016-2026
Product summary
- Event
- Event 97756
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 13080 bottles
- Official record key
drug-enforcement:D-0016-2026
Official wording
Reason: Discoloration
Code information: Lot#: T400819, T400820, Exp 4/30/26; T401969, Exp 9/30/26
Distribution pattern: USA Nationwide
Derived failure modes
-
Unknown
Discoloration