FDA recall D-0011-2025

Product

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

Distribution

NY

Key facts

Status

Ongoing

Initiation date

2024-09-24

Report date

2024-10-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cranford, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0011-2025