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American Regent Initiates Voluntary Recall of Magnesium Sulfate Injection, USP 50% (25 grams/50 mL), 50mL Single Dose Vial Lot # 0491
Date:11/5/2010

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 Magnesium Sulfate 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."

American Regent will credit accounts for all returned Magnesium Sulfate Injection, USP product with Lot # 0491. Those with questions about the return process, please call our Customer Service Department at 1-800-645-1706: Monday thru Friday from 8:30 AM to 7:00 PM ET.

Hospitals, infusion centers, clinics and healthcare providers, or patients with other questions may contact the Professional Services Department at 631-924-4000.

Any adverse reactions experienced with the use of this product, and/or quality problems should be reported to American Regent, Inc. via email at PV@luitpold.com, by fax to 610-650-7781 or 610-650-0170 or by phone at 1-800-734-'/>"/>

SOURCE Luitpold Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
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