Drug Enforcement D-0171-2025

Crystallization

Status

Ongoing

Classification

Class II

Report Date

January 8, 2025

Termination Date

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Product Information

Product description
Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack
Product quantity
23304 packs
Reason for recall
Crystallization
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
US Nationwide

Location & Firm

Recalling firm
VIONA PHARMACEUTICALS INC
Address
20 Commerce Dr Ste 340

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0171-2025
Event ID
95930
Recall initiation date
December 10, 2024
Center classification date
January 2, 2025
Code info
Lots T400513, Exp Date 02/2026; T400807, Exp Date 03/2026; T401152, Exp Date 06/2026; T401303, Exp Date 07/2026; T401304, Exp Date 07/2026; T401399, Exp Date 07/2026 & T401696 Exp Date 08/2026.
More code info
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