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Recall Observatory FDA recall evidence

Drug product

Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx only, Distributed by Viatris Specialty LLC, Morgantown, WV 26505, NDC 58151-079-93

D-0203-2025

December 23, 2024

Class II

Product summary

Firm
Viatris Inc
Event
Event 96036
Status
Terminated
Classification
Class II
Quantity
1,215/30 count bottles
Official record key
drug-enforcement:D-0203-2025

Official wording

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

Code information: Lot # 8181625, Exp 12/31/2025

Distribution pattern: USA nationwide.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of specification