PlainRecalls
FDA Drug Moderate Class II Ongoing

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.

Reported: October 23, 2024 Initiated: September 24, 2024 #D-0011-2025

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.

Reason for Recall

Crystallization

Details

Recalling Firm
VIONA PHARMACEUTICALS INC
Units Affected
2544 pumps
Distribution
NY
Location
Cranford, NJ

Frequently Asked Questions

What product was recalled?
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.. Recalled by VIONA PHARMACEUTICALS INC. Units affected: 2544 pumps.
Why was this product recalled?
Crystallization
Which agency issued this recall?
This recall was issued by the FDA Drug on October 23, 2024. Severity: Moderate. Recall number: D-0011-2025.