Phenylephrine HCl injection recalled
American Regent is undertaking a voluntary recall of Phenylephrine HCl Injection due to potential safety concerns stemming from the identification of visible particles found in retained samples.
The effected medication is labeled NDC#0517-0405-25, Lot # 0693 and has an expiration date of October, 2012.
The drug's primary indication is to maintain adequate BP during spinal and inhalation anesthesia, and for the treatment 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.
American Regent has not received any reports of adverse events related to this recall. Potential adverse events after IV administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation and granuloma formation.