Drug Enforcement D-0172-2025

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%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless pump pack
Product quantity
2760 packs
Reason for recall
Crystallization
Recall initiation reason
—
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
—

Codes & Dates

Recall number
D-0172-2025
Event ID
95930
Recall initiation date
December 10, 2024
Center classification date
January 2, 2025
Code info
Lots T400514, Exp Date 02/2026 & T400808, Exp Date 03/2026
More code info
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