Provepharm Recalls Phenylephrine HCl

Provepharm is recalling (Class 1) one lot of phenylephrine hydrochloride injection, USP, 10 mg/mL (pharmacy bulk package) due to a customer complaint about visible black particulate matter found in a single sealed vial. “Administration of an injectable product containing particulate matter may cause local irritation or swelling as a response to the foreign material,” a recall notice says. “If the particulate matter enters the blood vessels, it can travel to various organs and potentially blocking blood vessels in the heart, lungs or brain, leading to serious complications such as stroke or even death.

Provepharm says that to date it has not received any reports of adverse events or injuries associated with the recall. Phenylephrine is used for treating clinically important hypotension resulting primarily from vasodilation during the administration of anesthesia, according to the notice.