← FDA ENFORCEMENT
D-0603-2024Class II

Viatris Inc

Recalling firm
Viatris Inc
Product type
Drug
Status
Completed
Report date
2024-07-24
Distribution
U.S. Nationwide
Firm state
PA
Product quantity
3,694 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Failed Impurities/Degradation Specifications

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

Code / lot info

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

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.