Recalls / Class II

Class IID-0602-2024

Product

Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2040-10

Affected lot / code info

Lot #: 8147040; Exp. June 2024 Lot #: 8163764; 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

12,691 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-0602-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.