FDA-Drug2025-01-22Class II

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

Viatris Inc
Hazard

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

Sold states
USA nationwide.
Affected count
6,605/30 count bottles
Manufactured in
1000 Mylan Blvd, Canonsburg, PA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0204-2025

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