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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

SHIRLEY, N.Y., Nov. 5, 2010 /PRNewswire/ -- American Regent is conducting a nationwide voluntary recall of:

Magnesium Sulfate Injection, USP 50% (25 grams/50mL) 50 mL Single Dose Vial NDC # 0517-2650-25, Lot # 0491, Exp. Date: 8/2012

PLEASE NOTE: This recall, initiated on October 29, 2010 to the User Level, is for Lot # 0491 Only.  No other lots of Magnesium Sulfate Injection, USP are subject of this recall.

This voluntary recall was initiated because some vials of this lot were observed to be slightly discolored and upon standing have the appearance of sediment on the bottom of the vials.  American Regent is undertaking this recall in consideration of the potential for safety issues if this lot of product is administered to patients.

The product was distributed to wholesalers and distributors nationwide.

Hospitals, infusion centers, clinics and other healthcare facilities should not use American Regent Inc., Magnesium Sulfate Injection, USP, Lot# 0491, for patient care and should immediately quarantine any product for return.

"Patient safety is our primary concern, and we are committed to taking the necessary steps to protect patients from any potential safety risks," 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 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 1-800-734-9236. Adverse reactions may also be reported to FDA's MedWatch Adverse Event Reporting program online, or by returning the postage paid FDA form 3500, by mail to [MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or via fax [1-800-FDA-0178] or phone 1-800-332-1088.

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

About Luitpold Pharmaceuticals, Inc.

Luitpold Pharmaceuticals, Inc., headquartered in Shirley, NY, manufactures and distributes over 80 pharmaceutical products including Venofer® (iron sucrose injection, USP), the leading IV iron therapy in the U.S., through its human health subsidiary, American Regent, Inc. Luitpold Pharmaceuticals, Inc., a Daiichi Sankyo group company, also markets dental bone regeneration products and veterinary pharmaceuticals through its Osteohealth and Animal Health divisions. Daiichi Sankyo Company, Ltd., established in 2005 after the merger of two leading century-old Japanese pharmaceutical companies, is a global pharmaceutical innovator, continuously generating innovative drugs that enrich the quality of life for patients around the world.


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SOURCE Luitpold Pharmaceuticals, Inc.
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