FDAHealthDecember 10, 2024
VIONA PHARMACEUTICALS INC — Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-0
⚠️ Crystallization
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 10, 2024
US Nationwide
What's affected?
- Product
- Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless pump pack
- Brand
- DAPSONE
- Lot code
- T400514
Additional details
Lots T400514, Exp Date 02/2026 & T400808, Exp Date 03/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 2760 packs.
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