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
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.
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
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
about contacting American Regent or reporting adverse events to MedWatch is
FDA MedWatch (Accessed 2/23/2012)