FDAHealthDecember 23, 2024
Viatris Inc — 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
⚠️ Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 23, 2024
USA nationwide.
What's affected?
- 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
- Brand
- CARDURA
- UPC
- 0358151078936
- Lot code
- 8181625
Additional details
Lot # 8181625, Exp 12/31/2025
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1,215/30 count bottles.
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