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Recall Observatory FDA recall evidence

Drug product

Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., New York, NY 10017, NDC 0049-2710-30

D-1485-2014

June 19, 2014

Class III

Product summary

Firm
Pfizer Inc.
Event
Event 68639
Status
Terminated
Classification
Class III
Quantity
22,461 bottles
Official record key
drug-enforcement:D-1485-2014

Official wording

Reason: Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.

Code information: Lot # V130822; Exp 01/15

Distribution pattern: Nationwide (Continental USA and Puerto Rico). A portion of the bulk lot was supplied to Pfizer Germany for packaging into blisters for non- USA market. One of these lots in Germany was placed in stability having acceptable results, therefore are not part of the recall scope. Only the product distributed within US/PR market (bottles) is in the scope of this recall.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications