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Viona Pharmaceuticals Inc FDA Recalls

8 recalls on file across drugs, 0 of them Class I and 6 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, IClass IIOct 6, 2025Discoloration
Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus LifesciencClass IIAug 12, 2025Discoloration
Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona PharmClass IIDec 10, 2024Crystallization
Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona PharClass IIDec 10, 2024Crystallization
Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: VioClass IIOct 29, 2024Crystallization
Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: VioClass IISep 24, 2024Crystallization
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01Class IIDec 27, 2021CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA)
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx only, Manufactured by: Cadila Healthcare LClass IIJun 1, 2021CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA)

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