Sagent Pharmaceuticals Issues Voluntary Nationwide Recall for its Low Blood Pressure Treatment

Sagent Pharmaceuticals is voluntarily recalling three lots of Phenylephrine Hydrochloride Injection, USP (10 mg/mL) to the user level because of a customer complaint regarding potentially loose crimped vial overseals, which can result in a non-sterile product.

Sagent Pharmaceuticals announced on March 11, 2021 that it is voluntarily recalling three lots of Phenylephrine Hydrochloride Injection, USP (10 mg/mL), an alpha-1 adrenergic receptor agonist for the treatment of low blood pressure resulting from the dilation of blood vessels, to the user level because of a customer complaint regarding potentially loose crimped vial overseals, which can result in a non-sterile product.

Administering a product intended to be sterile but that is not sterile could result in systemic infections which may be life-threatening, FDA said in a press release. Sagent is recalling lot numbers PHT8IB2, PHT9IB2, and PHT1JB2 distributed nationwide in the US from Nov. 17, 2020 to March 8, 2021. Currently, the company has not received any reports of adverse events associated with the product.

Source: FDA