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American Regent recalls Phenylephrine HCl Injection

American Regent has issued voluntary recall of Phenylephrine HCl Injection, USP, Lot 0693 due to the potential identification of visible particles found in some retained samples.

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 and granuloma formation, the company said.

Phenylephrine HCl Injection is indicated for the maintenance of an adequate level of blood pressure during spinal and inhalation anesthesia and to treat vascular failure in shock, shock like states, and drug-induced hypotension, or hypersensitivity.

The product is also used to overcome paroxysmal supraventricular tachycardia, to prolong spinal anesthesia, and as a vasoconstrictor in regional analgesia.