Drug Enforcement D-0603-2024

Failed Impurities/Degradation Specifications

Status

Completed

Classification

Class II

Report Date

July 24, 2024

Termination Date

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Product Information

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
Product quantity
3,694 bottles
Reason for recall
Failed Impurities/Degradation Specifications
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
U.S. Nationwide

Location & Firm

Recalling firm
Viatris Inc
Address
1000 Mylan Blvd

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0603-2024
Event ID
94519
Recall initiation date
April 30, 2024
Center classification date
July 16, 2024
Code info
Lot#: 8147041; Exp. June 2024 Lot#: 8163765; Exp. March 2025
More code info
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