FDAClass IINovember 13, 2024

Dapsone Gel 7.5% recall

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.

Why was Dapsone Gel 7.5% recalled?

Crystallization

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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.
Recalling firm
VIONA PHARMACEUTICALS INC
Quantity
6048 pumps
Distribution
USA Nationwide
Recall date
November 13, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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