American Regent Issues Nationwide Recall of Sterile Water for Injection

Washington, DC: 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

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.

For further information on this recall visit: http://www.fda.gov/Safety/Recalls/ucm256061.htm The product was distributed to wholesalers and distributors nationwide.

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Published on May-20-11