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Recall Observatory FDA recall evidence

Drug 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 ***

D-033-2013

August 07, 2012

Class II

Product summary

Firm
Mylan Pharmaceuticals Inc.
Event
Event 63284
Status
Terminated
Classification
Class II
Quantity
24,331 bottles
Official record key
drug-enforcement:D-033-2013

Official wording

Reason: Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine.

Code information: Lot A 303M, Exp. June 2014

Distribution pattern: Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine.