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