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  3. Recall Enforcement Event ID: 94519

Recall Enforment Report D-0603-2024

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Viatris Inc, originally initiated on 04-30-2024 for the product 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 The product was recalled due to failed impurities/degradation specifications. The product was distributed nationwide and the recall is currently completed.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0603-202404-30-202407-24-2024Class II3,694 bottlesCardura 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 0049-2080-10Failed Impurities/Degradation SpecificationsCompleted
D-0602-202404-30-202407-24-2024Class II12,691 bottlesCardura 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 0049-2040-10Failed Impurities/Degradation SpecificationsCompleted