February 23, 2012

American Regent Recalls Phenylephrine HCl Injection Due To Visible Particles

The Missouri Department of Health and Senior Services received the following recall regarding Phenylephrine HCl Injection, USP, Lot 0693 due to potential safety concerns.

The product recall includes:

  • Phenylephrine HCl Injection, USP, 1% (10mg/mL), 5 mL Vial NDC # 0517-0405-25, Lot # 0693, Exp Date: October, 2012.

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 this product for patient care and should immediately quarantine any product for return.

The full recall announcement can be found at: www.fda.gov/Safety/Recalls/ucm292951.htm?source=govdelivery.