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American Regent Initiates Nationwide Voluntary Recall of Sodium Thiosulfate Injection, USP
Date:2/3/2011

safety of patients receiving our products is our primary concern," said Mary Jane Helenek, President and CEO of American Regent.

While American Regent continues to investigate this issue, the company is taking precautionary action and initiated this voluntary recall.  American Regent has informed the FDA of its actions and is maintaining ongoing discussions with the agency.

As is standard practice, and as stated in the Sodium Thiosulfate Injection, USP Product Package Insert, "Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit."

Sodium Thiosulfate Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).

This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.


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SOURCE Luitpold Pharmaceuticals, Inc.
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