← FDA ENFORCEMENT
D-0602-2024Class II

Viatris Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Viatris Inc
Product type
Drug
Status
Completed
Report date
2024-07-24
Distribution
U.S. Nationwide
Firm state
PA
Product quantity
12,691 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 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2040-10

Code / lot info

Lot #: 8147040; Exp. June 2024 Lot #: 8163764; Exp. March 2025

Data: U.S. FDA. 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. Open the enforcement explorer →