Drug Enforcement D-0011-2025

Crystallization

Status

Ongoing

Classification

Class II

Report Date

October 23, 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
2544 pumps
Reason for recall
Crystallization
Recall initiation reason
—
Initial firm notification
—
Distribution pattern
NY

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-0011-2025
Event ID
95412
Recall initiation date
September 24, 2024
Center classification date
October 12, 2024
Code info
Lot #: T400512, Exp 02/28/2026
More code info
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