RECALL: Phenylephrine HCl Injection Recall

American Regent is conducting a nationwide voluntary recall of Phenylephrine HCl Injection, USP, 1% (10mg/mL), 5mL vial (NDC#0517-0405-25, Lot # 0693, Exp Date: October, 2012).

American Regent is undertaking this voluntary recall of Phenylephrine HCl Injection 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 IV administration of solutions containing particulates may include disruption of blood flow within small blood vessels in the lung, localized inflammation, and granuloma formation.

Phenylephrine HCl Injection 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.

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