D-033-2013 Class II Terminated
FDA drug recall D-033-2013 was initiated by Mylan Pharmaceuticals Inc. on Aug 7, 2012 and is designated Class II. Reason for recall: Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine. The recall status is terminated (terminated Mar 27, 2013). Affected quantity: 24,331 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Oct 31, 2012
- Initiation Date
- Aug 7, 2012
- Termination Date
- Mar 27, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24,331 bottles
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 ***
Reason for recall
Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine.
Distribution pattern
Nationwide.
Code information
Lot A 303M, Exp. June 2014
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-033-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026