Drug Enforcement D-0204-2025

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.

Status

Ongoing

Classification

Class II

Report Date

January 22, 2025

Termination Date

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Product Information

Product description
Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-078-93
Product quantity
6,605/30 count bottles
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
USA nationwide.

Location & Firm

Recalling firm
Viatris Inc
Address
1000 Mylan Blvd

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

Recall number
D-0204-2025
Event ID
96036
Recall initiation date
December 23, 2024
Center classification date
January 16, 2025
Code info
Lot# 8182298, Exp 10/31/2025
More code info
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