Blood Pressure Injection Recalled

Athenex Pharma Solutions is recalling more than 19,000 bags of norepinephrine bitartrate injection because of defective containers, according to the March 30, 2022, US Food and Drug Administration (FDA) Enforcement Report.

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

• norepinephrine bitartrate injection in 0.9% sodium chloride, 4 mg per 250 mL, 250-mL Excel bag (NDC 76154-474-15), from lots F2101628, F2101629, F2101630, and F2101631 (Exp. 4/28/22); F2101632 and F2101633 (Exp. 4/29/22); and F2101795 and F2101796 (Exp. 5/27/22);
• norepinephrine bitartrate injection in 0.9% sodium chloride, 8 mg per 250 mL, 250-mL Excel bag (NDC 76154-475-15), from lots F2101639, F2101642, F2101644, and F2101645 (Exp. 4/30/22); F2101674, F2101675, and F2101676 (Exp. 5/5/22); F2101790, F2101791, F2101792, F2101793, and F2101794 (Exp. 5/26/22); and F2101813 (Exp. 5/29/22); and
• norepinephrine bitartrate injection in 0.9% sodium chloride, 16 mg per 250 mL, 250-mL Excel bag (NDC 76154-476-15), from lots F2101634 (Exp. 3/30/22); F2101665 and F2101666 (Exp. 4/2/22); F2101788 and F2101789 (Exp. 4/26/22); and F2101811, F2101812, and F2101815 (Exp. 4/29/22).

Athenex Pharma Solutions voluntarily initiated the recall March 14, 2022. On March 21, 2022, the FDA designated the recall Class II. 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.

Norepinephrine bitartrate injection is used to raise blood pressure in patients with severe, acute hypotension.