Recalling firm
VIONA PHARMACEUTICALS INC
Product type
Drug
Status
Ongoing
Report date
2024-11-13
Distribution
USA Nationwide
Firm state
NJ
Product quantity
6048 pumps
Initiated by
Voluntary: Firm initiated
Reason for recall
Crystallization
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.
Code / lot info
Lots T401151, Exp, 06/30/2026; T400806, Exp 03/31/2026
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.