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American Regent Initiates Nationwide Voluntary Recall Of Phenylephrine HCl Injection, USP, 1% 5 mL V

Thursday, February 23, 2012   (0 Comments)
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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


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.

Additional information about contacting American Regent or reporting adverse events to MedWatch is available at:


Source: FDA MedWatch (Accessed 2/23/2012)

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