American Regent Initiates Nationwide Voluntary Recall Of Phenylephrine HCl Injection, USP, 1% 5 mL Vial, Lot# 0693 Due To Visible Particles
Walter Tozzi, R.Ph., M.S., M.B.A.
Sr. Director of Professional Services
FOR IMMEDIATE RELEASE - February 22, 2012 - American Regent is conducting a nationwide voluntary recall to the Retail/Hospital level of the following product:
Phenylephrine HCl Injection, USP, 1% (10mg/mL), 5 mL Vial NDC # 0517-0405-25, Lot # 0693, Exp Date: October, 2012.
PLEASE NOTE: This recall, initiated on February 22, 2012 to the Retail/Hospital Level, is for Lot # 0693 only. No other lots or sizes of Phenylephrine HCl Injection, USP are subject to this voluntary recall.
American Regent is undertaking this voluntary recall of Phenylephrine HCl Injection, USP, Lot 0693 due to potential safety concerns stemming from the identification of visible particles found in some retained samples of this lot. American Regent has not received any reports of adverse events related to this recall.
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), and granuloma formation.
Phenylephrine HCl Injection, USP is intended for the maintenance of an adequate level of blood pressure during spinal and inhalation anesthesia and for the treatment of vascular failure in shock, shock like states, and drug-induced hypotension, or hypersensitivity. It is also employed to overcome paroxysmal supraventricular tachycardia, to prolong spinal anesthesia, and as a vasoconstrictor in regional analgesia.
The product was distributed to wholesalers and distributors nationwide.
Hospitals, Emergency Rooms, Clinics, and other healthcare facilities and providers should not use American Regent, Inc., Phenylephrine HCl Injection, USP, 1% (10mg/mL), 5 mL Vials, with Lot #0693, for patient care and should immediately quarantine any product for return.
American Regent is notifying its distributors and consumers by e-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 [email protected] 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.
Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm2. Mail to address on the pre-addressed form.
While American Regent continues to investigate this issue, the company is taking precautionary action and initiated this voluntary recall. American Regent has informed the FDA of its actions and is maintaining ongoing discussions with the agency.
As is standard practice, "Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit."
Phenylephrine HCl Injection, USP is manufactured by Luitpold Pharmaceuticals, Inc. and is distributed by American Regent, Inc. (Shirley, NY).
Source: Luitpold Pharmaceuticals, Inc.
This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.