Recalls / Class II

Class IID-0603-2024

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

Affected lot / code info

Lot#: 8147041; Exp. June 2024 Lot#: 8163765; Exp. March 2025

Why it was recalled

Failed Impurities/Degradation Specifications

Recalling firm

Firm

Viatris Inc

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

1000 Mylan Blvd, Canonsburg, Pennsylvania 15317-5853

Distribution

Quantity

3,694 bottles

Distribution pattern

U.S. Nationwide

Timeline

Recall initiated

2024-04-30

FDA classified

2024-07-16

Posted by FDA

2024-07-24

Status

Completed

Source: openFDA Drug Enforcement endpoint. Recall record D-0603-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.