Drug Enforcement D-0038-2025

Crystallization

Status

Ongoing

Classification

Class II

Report Date

November 13, 2024

Termination Date

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Product Information

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.
Product quantity
6048 pumps
Reason for recall
Crystallization
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA Nationwide

Location & Firm

Recalling firm
VIONA PHARMACEUTICALS INC
Address
20 Commerce Dr Ste 340, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0038-2025
Event ID
95650
Recall initiation date
October 29, 2024
Center classification date
November 5, 2024
Code info
Lots T401151, Exp, 06/30/2026; T400806, Exp 03/31/2026
More code info
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