Why it was recalled
Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine.
Product description
Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactured in Australia by: ALPHAPHARM PTY LTD, 15 Garnet Street***Rx Only*** Carole Park QLD 4300, Australia*** Manufactured for Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.SA ***
Lot numbers, UPCs & expiration codes
Lot A 303M, Exp. June 2014
Where it was sold
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-033-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 7, 2012
- FDA report date
- Oct 31, 2012
- Quantity
- 24,331 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-033-2013, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 63284
- Address
- 781 Chestnut Ridge Rd
- Code information
- Lot A 303M, Exp. June 2014
- Postal code
- 26505-2730
- Report date
- Oct 31, 2012
- Product type
- Drugs
- Recall number
- D-033-2013
- Classification
- Class II
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Product quantity
- 24,331 bottles
- Termination date
- Mar 27, 2013
- Reason for recall
- Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Doxazosin Tablets, USP, 2 mg, 100 count bottles, labeled in part ***Manufactured in Australia by: ALPHAPHARM PTY LTD, 15 Garnet Street***Rx Only*** Carole Park QLD 4300, Australia*** Manufactured for Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.SA ***
- Distribution pattern
- Nationwide.
- Recall initiation date
- Aug 7, 2012
- Initial firm notification
- Letter
- Center classification date
- Oct 25, 2012