Recalls / Class II
Class IID-033-2013
Product
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 ***
- Affected lot / code info
- Lot A 303M, Exp. June 2014
Why it was recalled
Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, N/A, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 24,331 bottles
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2012-08-07
- FDA classified
- 2012-10-25
- Posted by FDA
- 2012-10-31
- Terminated
- 2013-03-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-033-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.