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
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
Failed Impurities/Degradation Specifications