Why it was recalled
Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.
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
Lot numbers, UPCs & expiration codes
Lot # V130822; Exp 01/15
Where it was sold
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.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1485-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 19, 2014
- FDA report date
- Aug 6, 2014
- Quantity
- 22,461 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-1485-2014, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 68639
- Address
- 235 East 42nd Street
- Code information
- Lot # V130822; Exp 01/15
- Postal code
- 10017-5703
- Report date
- Aug 6, 2014
- Product type
- Drugs
- Recall number
- D-1485-2014
- Classification
- Class III
- Recalling firm
- Pfizer Inc.
- Product quantity
- 22,461 bottles
- Termination date
- Jun 3, 2015
- Reason for recall
- Failed Impurities/Degradation Specifications: Product from this lot may not meet specifications for a product degradant.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- 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.
- Recall initiation date
- Jun 19, 2014
- Initial firm notification
- Letter
- Center classification date
- Jul 28, 2014