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
Reported: August 6, 2014 Initiated: June 19, 2014 #D-1485-2014
Product Description
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.
Details
- Recalling Firm
- Pfizer Inc.
- Units Affected
- 22,461 bottles
- 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.
- Location
- New York, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Pfizer Inc.. Units affected: 22,461 bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 6, 2014. Severity: Low. Recall number: D-1485-2014.
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