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American Regent Initiates Nationwide Voluntary Recall of Potassium Phosphates Injection, USP, 15 mM/5 mL Phosphorus; 22 mEq/5 mL Potassium, 5 mL Single Dose Vial, Lot # 0048 Due to Translucent Visible Particles
Date:2/3/2011

SHIRLEY, N.Y., Feb. 3, 2011 /PRNewswire/ -- American Regent is conducting a nationwide voluntary recall to the consumer and user level of the following product:Potassium PhoshaesInjection,USP,15mM/5 mLPhoshorus;22mEq/5mLoassium5mLSingleDoseVialNDC# 0517-2305-25Lot # 0048ExpDate:  January,2012PLEASE NOTE:  This recall, initiated on February 3, 2011 to the User or Consumer Level, is for lot # 0048 Only.  No other lots or sizes of Potassium Phosphates Injection, USP are subject to this voluntary recall.This voluntary recall was initiated because some vials of this lot exhibit translucent visible particles consistent with glass delamination.

Potential adverse events after intravenous administration include damage to blood vessels in the lung, localized swelling, and granuloma formation.  American Regent is undertaking this recall in consideration of the potential for safety issues if this lot of product is administered to patients.

Potassium Phosphates Injection, USP, 3 mM Phosphorus/mL, is indicated as a source of phosphorus, for addition to large volume intravenous fluids to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific intravenous fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.

The product was distributed to wholesalers and distributors nationwide.

Hospitals, Home Health Care Agencies, Emergency Rooms, Infusion Centers, Clinics and other healthcare facilities should not use American Regent, Inc., Potassium Phosphates Injection, USP, 15 mM/5 mL Phosphorus; 22 mEq/5 mL Potassium, 5
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SOURCE Luitpold Pharmaceuticals, Inc.
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