Recall
FDAHealthOctober 29, 2024

VIONA PHARMACEUTICALS INC — 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 725

⚠️ Crystallization

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
October 29, 2024

USA Nationwide

What's affected?

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.
Brand
DAPSONE
Lot code
T401151

Additional details

Lots T401151, Exp, 06/30/2026; T400806, Exp 03/31/2026

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 6048 pumps.

View original FDA notice →

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