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D-0011-2025Class II
VIONA PHARMACEUTICALS INC
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
VIONA PHARMACEUTICALS INC
Product type
Drug
Status
Ongoing
Report date
2024-10-23
Distribution
NY
Firm state
NJ
Product quantity
2544 pumps
Initiated by
Voluntary: Firm initiated
Reason for recall
Crystallization
Product description
Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02.
Code / lot info
Lot #: T400512, Exp 02/28/2026
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →