Blood Pressure Injection Recalled

Almost 380,000 vials of nicardipine hydrochloride injection distributed by AuroMedics Pharma are being recalled for organic impurities, according to the March 27, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following products, which were distributed throughout the United States:

• nicardipine hydrochloride injection, 25 mg per 10 mL (2.5 mg/mL), 10 x 10-mL single-dose vials (NDC 55150-183-10), from lots 3NC23002 (Exp. 7/24); 3NC22013 3NC22014, 3NC22015, 3NC22016, 3NC22017, and 3NC22018 (Exp. 2/24); and 3NC22020 (Exp. 3/24); and
• nicardipine hydrochloride injection, 25 mg per 10 mL (2.5 mg/mL), 10 x 10-mL single-dose vials (NDC 55150-183-11), from lot 3NC22019 (Exp. 2/24).

Eugia US voluntarily initiated the recall on February 20, 2024. On March 19, 2024, the FDA designated the recall Class II, communicating use of the drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Nicardipine hydrochloride injection is a prescription drug indicated for the short-term treatment of hypertension when oral therapy is not feasible.