D-0603-2024 Class II
FDA drug recall D-0603-2024 was initiated by Viatris Inc on April 30, 2024 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications Affected quantity: 3,694 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 24, 2024
- Initiation Date
- April 30, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,694 bottles
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution Pattern
U.S. Nationwide
Code Information
Lot#: 8147041; Exp. June 2024 Lot#: 8163765; Exp. March 2025