Recalls / Class III
Class IIID-1485-2014
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
- Affected lot / code info
- Lot # V130822; Exp 01/15
Why it was recalled
Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.
Recalling firm
- Firm
- Pfizer Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 East 42nd Street, New York, New York 10017-5703
Distribution
- Quantity
- 22,461 bottles
- 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.
Timeline
- Recall initiated
- 2014-06-19
- FDA classified
- 2014-07-28
- Posted by FDA
- 2014-08-06
- Terminated
- 2015-06-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1485-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.