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American Regent Initiates Nationwide Voluntary Recall of Phenylephrine HCl Injection, USP, 1%, 5 mL Vial, Lot# 0693, Due to Visible Particles
Date:2/22/2012

-mail, facsimile and/or overnight courier and is arranging for return of all recalled product.  Consumers/distributors/retailers that have product which is being recalled should stop use.

American Regent will credit accounts for all returned Phenylephrine HCl Injection, USP, 1% (10mg/mL), 5 mL Vials, with Lot # 0693. Those with questions about the return or recall process, please call our Customer Service Department at 1- 800-645-1706: Monday thru Friday from 8:30 AM to 7:00 PM ET.

Hospitals, emergency rooms, clinics, and other healthcare facilities and 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: Monday thru Friday from  9:00 AM to 5:00 PM ET.

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: Monday thru Friday from 9:00 AM to 5 PM ET.  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/lot may be reported to the FDA's MedWatch Adverse Event Reporting program online, by regular mail or by fax.


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SOURCE Luitpold Pharmaceuticals, Inc.
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