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.
American Regent is undertaking this 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.
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.
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).
See the FDA Recall