D-0171-2025 Class II Ongoing
FDA drug recall D-0171-2025 was initiated by VIONA PHARMACEUTICALS INC on December 10, 2024 and is designated Class II. Reason for recall: Crystallization The recall status is ongoing. Affected quantity: 23304 packs.
Recall Details
- Product Type
- Drugs
- Report Date
- January 8, 2025
- Initiation Date
- December 10, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23304 packs
Product Description
Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack
Reason for Recall
Crystallization
Distribution Pattern
US Nationwide
Code Information
Lots T400513, Exp Date 02/2026; T400807, Exp Date 03/2026; T401152, Exp Date 06/2026; T401303, Exp Date 07/2026; T401304, Exp Date 07/2026; T401399, Exp Date 07/2026 & T401696 Exp Date 08/2026.