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Article: Actavis Totowa cited for failures in reporting, stability testing.(HUMAN DRUGS)
- Article from:
- Inspection Monitor
- Article date:
- November 1, 2008
CopyrightCOPYRIGHT 2008 Washington Information Source, Inc. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Actavis Totowa, Little Falls, NJ Parsippany District
Following an inspection Sept. 5-28, 2007, FDA Investigator Kristy Zielny issued a three-item 483 to Actavis Totowa, a maker of generic drugs.
In April 2008, the firm initiated a Class I nationwide recall of Digitek (digoxin tablets, USP) for oral use. The products are distributed by Mylan Pharmaceuticals under a "Bertek" label and by UDL Laboratories under a "UDL" label, according to a company news release.
The voluntary all-lot recall was due to the possibility that tablets with double the appropriate thickness may have been commercially released, the firm noted. Actavis said the tablets may ...
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Article: Digitek Debacle - Actavis Totowa Accused of ...
Heart Disease Weekly;
August 10, 2008 ;
700+ words
...A Federal lawsuit filed in Birmingham, Alabama July 18, 2008 charges pharmaceutical company Actavis Totowa with manufacturing and distributing defective Digitek heart drug pills that contained dangerously excessive doses of the drug ...
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