VIONA PHARMACEUTICALS INC: Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- VIONA PHARMACEUTICALS INC
- 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.
- Reason / hazard
- Discoloration
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- USA Nationwide
- Recall initiated
- 2025-10-06
- Code info
- Lot#: T400819, T400820, Exp 4/30/26; T401969, Exp 9/30/26
- Product quantity
- 13080 bottles
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Cranford
- State
- NJ
- Country
- United States
- Event id
- 97756
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