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Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, Ind...

FDA Recall #D-0011-2025 — Class II — September 24, 2024

Recall #D-0011-2025 Date: September 24, 2024 Classification: Class II Status: Ongoing

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

2544 pumps

Distribution

NY

Code Information

Lot #: T400512, Exp 02/28/2026

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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