Hypotension Injection Recalled

Defective containers have prompted Athenex Pharma Solutions to recall 4450 bags of phenylephrine hydrochloride injection, 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:

• phenylephrine hydrochloride injection in .9% sodium chloride, 20 mg per 250 mL, 250-mL excel bag (NDC 76154-491-15), from lots F2101654 (Exp. 5/30/22), F2101834 (Exp. 7/3/22), and F2200110 (Exp. 7/27/22);
• phenylephrine hydrochloride injection in .9% sodium chloride, 40 mg per 250 mL, 250-mL excel bag (NDC 76154-493-15), from lot F2101651 (Exp. 5/30/22); and
• phenylephrine hydrochloride injection in .9% sodium chloride, 50 mg per 250 mL, 250-mL excel bag (NDC 76154-494-15), from lots F2101652 and F2101653 (Exp. 5/30/22) and F2200111 (Exp. 7/27/22).

Athenex Pharma Solutions voluntarily initiated the recall March 14, 2022. The FDA designated the recall Class II on March 21, 2022, communicating that use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Phenylephrine hydrochloride injection is used to raise blood pressure in patients with clinically important hypotension that may occur during surgery.