Status
Terminated
Drug Enforcement D-033-2013
Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine.
Classification
Class II
Report Date
October 31, 2012
Termination Date
March 27, 2013
Product Information
- 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 ***
- Product quantity
- 24,331 bottles
- Reason for recall
- Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide.
Location & Firm
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Address
-
781 Chestnut Ridge Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-033-2013
- Event ID
- 63284
- Recall initiation date
- August 7, 2012
- Center classification date
- October 25, 2012
- Code info
- Lot A 303M, Exp. June 2014
- More code info
- —