The particular product is “Phenylephrine HCl Injection, USP, 1% (10mg/mL), 5 mL Vial NDC # 0517-0405-25, Lot # 0693 only, Exp Date: October 2012.” American Regent is undertaking this voluntary recall of the product due to potential safety concerns stemming from the identification of visible particles found in some retained samples of this lot.
Although American Regent has not received any reports of an adverse event, 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.
Related Articles on Device Safety:
Emergency Medicine Foundation Releases Brief on Safe Injection Practices
AAMI Calls for Collaboration on CMS Memo on Medical Devices
CoxHealth in Missouri Settles Third of Radiation Overdose Cases
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