Why it was recalled
Failed Impurities/Degradation Specifications
Product description
Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2040-10
Lot numbers, UPCs & expiration codes
Lot #: 8147040; Exp. June 2024 Lot #: 8163764; Exp. March 2025
Where it was sold
U.S. Nationwide
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-0602-2024
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Apr 30, 2024
- FDA report date
- Jul 24, 2024
- Quantity
- 12,691 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Viatris Inc
Original FDA data
Every field from FDA enforcement report D-0602-2024, exactly as published.
Show all FDA fields
- City
- Canonsburg
- State
- PA
- Status
- Completed
- Country
- United States
- Event ID
- 94519
- Address
- 1000 Mylan Blvd
- Code information
- Lot #: 8147040; Exp. June 2024 Lot #: 8163764; Exp. March 2025
- Postal code
- 15317-5853
- Report date
- Jul 24, 2024
- Product type
- Drugs
- Recall number
- D-0602-2024
- Classification
- Class II
- Recalling firm
- Viatris Inc
- Product quantity
- 12,691 bottles
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cardura XL (doxazosin) extended release tablets 4mg, 30-count bottles, Rx Only, Made in Singapore, Distributed by Roerig Division of Pfizer Inc, NY, NY 10017 NDC 0049-2040-10
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Apr 30, 2024
- Initial firm notification
- Letter
- Center classification date
- Jul 16, 2024