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American Regent Initiates Voluntary Nationwide Recall of Concentrated Sodium Chloride Injection, USP, 23.4%, 30 mL Single Dose Vial Due to Particulates
Date:6/15/2011

e inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit."  

American Regent will credit accounts for all returned product with this lot #. Those with questions about the return or recall process, please call our Customer Service Department at 1-877-788-3232: Monday thru Friday from 8:30AM to 7:00PM EDT.

Hospitals, emergency rooms, infusion centers, clinics and healthcare providers, or patients with product quality complaints, medical or other questions concerning the use of the product or reasons for this recall should contact the Professional Services Department at 1-877-788-3232.  

Any adverse reactions experienced with the use of this product should be reported to American Regent, Inc. via e-mail at pv@luitpold.com, by fax to (610) 650-0170 or by phone at 1-800-734-9236.  TO EXPEDITE HANDLING, PLEASE DO NOT REPORT ANYTHING OTHER THAN SPECIFIC ADVERSE EVENTS TO THIS E-MAIL ADDRESS OR FAX OR PHONE.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, or by fax.


Concentrated Sodium Chloride Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).

This voluntary recall is being conducted with the knowledge of the U.S. Food & Drug Administration
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SOURCE Luitpold Pharmaceuticals, Inc.
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