Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, Ind...
FDA Recall #D-0038-2025 — Class II — October 29, 2024
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
Recalling Firm
VIONA PHARMACEUTICALS INC — Cranford, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
6048 pumps
Distribution
USA Nationwide
Code Information
Lots T401151, Exp, 06/30/2026; T400806, Exp 03/31/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated