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American Regent Initiates Nationwide Voluntary Recall of Sodium Bicarbonate Injection, USP 7.5% and 8.4%, 50 mL Single Dose Vials Due to Particulate Matter
Date:12/23/2010

at have product which is being recalled should stop use.

American Regent will credit accounts for all returned product with these lot #'s. Those with questions about the return process, please call our Customer Service Department at 1-800-645-1706: Monday thru Friday from 8:30AM to 7:00PM ET.

Hospitals, infusion centers, clinics and healthcare providers, or patients with other questions may contact the Professional Services Department at 800-645-1706.

Any adverse reactions experienced with the use of this product, and/or quality problems should be reported to American Regent, Inc. viaemailaPV@luitpold.com, byfaxo 610-650-7781or 610-650-0170 orbyphoneat 1-800-734-9236.

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, or regular mail or by fax.

Online: www.fda.gov/medwatch/report.htm

Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm . Mail to address on the pre-addressed form.

Fax: 1-800-FDA-0178

Sodium Bicarbonate 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 and Drug Administration.

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SOURCE Luitpold Pharmaceuticals, Inc.
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