Viatris Inc: Drug Recall

Recall #D-0603-2024 · 04/30/2024

Class II: Risk

Recall Details

Recall Number: D-0603-2024
Classification: Class II
Product Type: Drug
Recalling Firm: Viatris Inc
Status: Completed
Date Initiated: 04/30/2024
Location: Canonsburg, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,694 bottles

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

Distribution Pattern

U.S. Nationwide

Other Recalls by Viatris Inc

Class II: Risk 12/23/2024

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Class II: Risk 12/23/2024

Failed Impurities/Degradation Specifications: Out of specification results observed for the impurity compound B during stability testing.
Class II: Risk 11/18/2024

Superpotent Drug and Subpotent Drug: potency failures obtained
Class II: Risk 11/18/2024

Superpotent Drug and Subpotent Drug: potency failures obtained
Class II: Risk 11/18/2024

Superpotent Drug and Subpotent Drug: potency failures obtained

View all recalls by Viatris Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.