Pfizer Inc. recalls Cardura XL (doxazosin mesylate extended release tablets, 4 mg, 30-count bottle, Rx only, Distributed by Roerig Division
Recalled August 6, 2014 · FDA recall D-1485-2014 · Pfizer
Hazard
Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant. · FDA Class III
Units
22,461 bottles
Sold at
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.
Description
Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.
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
Manufacturer(s)
Pfizer Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →