Blood Pressure Injections Recalled

Apollo Care LLC, Columbia, Missouri, is recalling 2265 syringes containing phenylephrine injection and 682 bags containing norepinephrine injection distributed in its home state. According to the May 24, 2023, US Food and Drug Administration (FDA) Enforcement Report, the recalls were initiated due to a lack of sterility assurance.

The recall affects the following products, which were distributed in Missouri:

• phenylephrine hydrochloride injection, 1 mg per 10 mL (100 mcg/mL), single-use syringe for IV use (NDC 71170-010-10), from lots AC-016606 (Exp. 5/6/23), AC-016636 (Exp. 7/9/23), and AC-016643 (Exp. 7/31/23); and
• norepinephrine 4 mg added to 250 mL of 5% dextrose injection (NDC 71170-500-25), from lots AC-016640 (Exp. 6/16/23) and AC-016670 (Exp. 8/29/23).

Apollo Care voluntarily initiated the recalls May 2, 2023. The FDA designated them Class II on May 18, 2023. 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.

Both phenylephrine and norepinephrine injections are used to increase blood pressure in adult patients with clinically significant hypotension.