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American Regent Initiates Voluntary Nationwide Recall of Concentrated Sodium Chloride Injection, USP, 23.4% 30 mL Single Dose Vials and 100 mL Pharmacy Bulk Packs
Date:3/15/2011

SHIRLEY, N.Y., March 15, 2011 /PRNewswire/ -- American Regent is conducting a voluntary nationwide recall of the following products:ConcentatedSodium Chloide Injection, USP, 23.4%, 30 mL Single Dose Vial NDC# 0517-2930-25andConcentatedSodiumChlorideInjection,USP, 23.4%,100 mL PharmacyBulkackage NDC# 0517-2900-25PLEASE NOTE:  This voluntary nationwide recall, initiated on March 15, 2011 to the User Level, is for Concentrated Sodium Chloride Injection, USP 23.4%, 30 mL Single Dose Vials and 100mL Pharmacy Bulk Packages. See attached APPENDIX for ALL the lots subject to this recall.This voluntary recall was initiated because some of the vials of these lots may contain visible particulates.  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 due to accumulation of inflammatory cells), and granuloma formation.   American Regent is undertaking this voluntary recall in consideration of the potential for safety issues if these lots of product are administered to patients.

Concentrated Sodium Chloride Injection, USP, 23.4% is indicated as an additive in parenteral fluid therapy for use in patients who have special problems of sodium electrolyte intake or excretion. It is intended to meet the specific requirement of the patient with unusual fluid and electrolyte needs.

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SOURCE Luitpold Pharmaceuticals, Inc.
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