FDA-Drug2014-08-06Class III
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
Pfizer Inc.
Hazard
Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.
Sold states
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.
Affected count
22,461 bottles
Manufactured in
235 East 42nd Street, New York, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1485-2014Don't want to check this manually?
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