FDAFDA · Food and drugs·Recall number D-1485-2014
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
Published August 6, 2014 · Recall initiated: June 19, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Pfizer Inc.
- Distributor
- 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.
- Lot
- Lot # V130822; Exp 01/15
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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