March 11, 2021
Sagent Pharmaceuticals has voluntarily recalled three lots of Phenylephrine Hydrochloride (HCl) Injection, USP (10mg/mL), which was manufactured by Indoco Remedies and distributed by Sagent. The recall is due to a customer complaint regarding potentially loose crimped vial overseals, which could compromise product sterility.
Phenylephrine HCl injection is indicated for intravenous (IV) administration to treat clinically important low blood pressure due to dilation of blood vessels, which can decrease blood pressure in the setting of anesthesia. IV administration of non-sterile phenylephrine HCl could cause serious, potentially life- threatening systemic infections. Sagent has stated that although the risk is small, it cannot be eliminated. The company has not received reports of any adverse events as of the date of the recall.
Sagent advises hospitals, distributors, and wholesalers who may be in possession of the recalled product to examine their inventory immediately, halt distribution of the product, and return it to Sagent. Patients who may have experienced problems related to the recalled phenylephrine HCl should contact their healthcare provider. Adverse events can also be reported to the U.S. FDA’s MedWatch program.
A full copy of the recall announcement is available on the FDA’s website.
There is no impact to members through Benecard Central Fill.