Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Dist...
FDA Recall #D-0172-2025 — Class II — December 10, 2024
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
Recalling Firm
VIONA PHARMACEUTICALS INC — Cranford, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2760 packs
Distribution
US Nationwide
Code Information
Lots T400514, Exp Date 02/2026 & T400808, Exp Date 03/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated