Viona Pharmaceuticals Inc. is recalling 3,960 bottles of Tavaborole Topical Solution 5% (10 mL per glass bottle) because the medication has shown signs of discoloration. This prescription medicine is used for the topical treatment of fungal infections. The recall affects specific bottles manufactured in India by Zydus Lifesciences Ltd. and distributed across the United States.
Discoloration in a topical medication can indicate chemical instability or a change in the drug's formulation, which may result in the medication being less effective or potentially causing unexpected skin irritation.
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Manufactured by: Zydus Lifesciences Ltd., Changodar Ahmedabad, India; Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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