Tavaborole topical solution recalled after discoloration found in one lot
Tavaborole Topical Solution 5%, 10 mL bottles from lot T401968, distributed by Viona Pharmaceuticals, is recalled because of discoloration. 3,960 bottles are affected.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Rubric level 2 covers precautionary recalls; the only issue stated is discoloration, with no health consequence described in the notice.
Plain-English summary
Tavaborole Topical Solution 5%, supplied in 10 mL glass bottles for topical use on prescription only, NDC 72578-102-04, is being recalled. The product is manufactured by Zydus Lifesciences Ltd. in Changodar, Ahmedabad, India and distributed by Viona Pharmaceuticals Inc. of Cranford, New Jersey. The affected product is lot T401968, and the recall covers 3,960 bottles distributed nationwide.
The recall was issued because of discoloration. The FDA classified the action as Class II. The notice does not describe any further consequence.
Patients should check the lot number on their bottle against the recall and speak to their pharmacist about a replacement supply.
The recalled product
- Product
- TAVABOROLE (TAVABOROLE)
- Brand
- TAVABOROLE
- Manufacturer
- VIONA PHARMACEUTICALS INC
- Category
- Drug — Topical
- Affected units
- 3,960
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: T401968
Distribution
Distributed nationwide across the United States.
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