Drug Enforcement D-0595-2025

Discoloration

Status

Ongoing

Classification

Class II

Report Date

August 27, 2025

Termination Date

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Product Information

Product description
Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd., Changodar Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016. NDC: 72578-102-04
Product quantity
3960 bottles
Reason for recall
Discoloration
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

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

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

Recall number
D-0595-2025
Event ID
97424
Recall initiation date
August 12, 2025
Center classification date
August 21, 2025
Code info
Lot #: T401968
More code info
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