DAPSONE Recall D-0038-2025
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.
DAPSONE Recall D-0038-2025 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0038-2025 |
| Event ID | 95650 |
| Brand | DAPSONE |
| Generic Name | DAPSONE |
| Manufacturer | DAPSONE |
| Original Package? | 1 |
| Active Substance | DAPSONE |
| Drug Route | TOPICAL |
| Distribution | USA Nationwide |
| Quantity | 6048 pumps |
| Recall Reason | Crystallization |
| Drug Classification | Class II |
| Drug Code Info | 20241113 |
| Product NDC | 72578-094 |
| Product NUI | N0000175881 M0020791 |
| Pharma Class (EPC) | Sulfone [EPC] |
| Pharma Class (CS) | Sulfones [CS] |
| Recall Initiation Date | 20241029 |
| Report Date | 20241113 |
| Classification Date | 20241105 |
| Address | 20 Commerce Dr Ste 340N/A Cranford, NJ 07016-3617 United States |
| Recalling Firm | VIONA PHARMACEUTICALS INC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 8W5C518302 |
| Drug Application Number | ANDA214019 |
| Structured Product Labeling (SPL ID) | fbed711e-945e-46aa-8883-fee0b7604485 |
| Structured Product Labeling (SPL Set ID) | 30867c69-cf3c-4360-8e56-db96e0b0c3ab |
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