FDA recall D-0602-2024

Viatris Inc · Class II · drug

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

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

U.S. Nationwide

Key facts

Status
Completed
Initiation date
2024-04-30
Report date
2024-07-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Canonsburg, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0602-2024