FDA recall D-1485-2014

Pfizer Inc. · Class III · 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

Reason for recall

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

Distribution

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.

Key facts

Status
Terminated
Initiation date
2014-06-19
Report date
2014-08-06
Termination date
2015-06-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
New York, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1485-2014