PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: January 8, 2025 Initiated: December 10, 2024 #D-0172-2025

Product Description

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

Reason for Recall

Crystallization

Details

Recalling Firm
VIONA PHARMACEUTICALS INC
Units Affected
2760 packs
Distribution
US Nationwide
Location
Cranford, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by VIONA PHARMACEUTICALS INC. Units affected: 2760 packs.
Why was this product recalled?
Crystallization
Which agency issued this recall?
This recall was issued by the FDA Drug on January 8, 2025. Severity: Moderate. Recall number: D-0172-2025.