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American Regent Initiates Nationwide Voluntary Recall of Sterile Water for Injection, USP, 50 mL Single Dose Vial Due to Particulate Matter
Date:5/19/2011

SHIRLEY, N.Y., May 19, 2011 /PRNewswire/ -- American Regent is conducting a nationwide voluntary recall to the consumer and user level of the following product:

Sterile Water for Injection, USP, 50 mL Single Dose Vial,

NDC # 0517-3050-25, Lot 0092, Exp. Date February, 2014



PLEASE NOTE: This recall, initiated on May 19, 2011 to the User or Consumer Level, is for Lot 0092 Only. No other lots or sizes of Sterile Water for Injection, USP are subject to this voluntary recall.

This voluntary recall was initiated because some of the vials of this lot may contain rust like particulate matter. Potential adverse events after intravenous administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation (swelling and redness), and granuloma formation. American Regent is undertaking this voluntary recall in consideration of the potential for safety issues, if this lot of Sterile Water for Injection, USP is administered to patients.

Sterile Water for Injection, USP is to be used only as a diluent. It is not isotonic and should not be injected directly into the body.

The product was distributed to wholesalers and distributors nationwide.

Hospitals, Emergency Rooms, Clinics, Physician Offices and other healthcare facilities and providers should not use American Regent Inc., Sterile Water for Injection, USP, 50 mL Single Dose Vials, with Lot 0092, for patient care and should immediately quarantine any product for return.

American Regent is notifying its distributors and consumers by email, facsimile and/or overnight courier and is arranging for return of all recalled product. Consumers/distributors/retailers that have product which is being recalled should stop use.

American Regent will credit accounts
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SOURCE Luitpold Pharmaceuticals, Inc.
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