Blood Pressure Injection Recalled

Citing potential cross contamination, Nephron Sterile Compounding Center is recalling 34,020 vials of labetalol hydrochloride injection, according to the November 23, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects PF-Labetalol HCl Injection in 20 mg/4 mL (5 mg/mL) vials (NDC 69374-946-34, UPC 3 69374 94634 6) from lots LB2001B (Exp. 1/7/23) and LB2005B (Exp. 3/2/23). The vials were distributed throughout the United States.

Nephron Sterile Compounding Center voluntarily initiated the recall November 10, 2022. The FDA designated the recall Class II on November 17, 2022. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Labetalol hydrochloride injection is a prescription medication used for the control of blood pressure in patients with severe hypertension.