March 26, 2021
Sterility concerns have prompted Sagent Pharmaceuticals Inc. to voluntarily recall 3716 cartons of phenylephrine hydrochloride injection. According to the March 24, 2021, US Food and Drug Administration (FDA) Enforcement Report, customers have reported vials with loose, crimped seals.
The recall affects phenylephrine hydrochloride injection for intravenous use, 10 mg/mL, 1-mL per single-dose vial, packaged in 25 x 1-mL single-dose vials per carton (NDC 25021-315-01), from lots PHT8IB2 (Exp. 8/22), PHT9IB2 (Exp. 8/22), and PHT1JB2 (Exp. 9/22). The product was made in India and distributed throughout the United States and in Puerto Rico.
Sagent Pharmaceuticals initiated the recall March 11, 2021. The FDA designated the recall Class II on March 17, 2021. Per the classification, use of the affected product may cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Phenylephrine hydrochloride injection is a prescription vasoconstrictor for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.