Class III
Terminated
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
This recall has been terminated (originally issued August 6, 2014).
- Company
- Pfizer Inc.
- Recall Initiated
- June 19, 2014
- Posted
- August 6, 2014
- Recall Number
- D-1485-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 22,461 bottles
- Firm Location
- New York, NY, United States
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot # V130822; Exp 01/15
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