Drug product
Cardura XL (doxazosin) extended release tablets 8mg, 30-count bottles, Rx Only Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2080-10
D-0603-2024
Product summary
- Firm
- Viatris Inc
- Event
- Event 94519
- Status
- Completed
- Classification
- Class II
- Quantity
- 3,694 bottles
- Official record key
drug-enforcement:D-0603-2024
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot#: 8147041; Exp. June 2024 Lot#: 8163765; Exp. March 2025
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications