Apollo Care Recalls Antibiotic Injections

Sterility concerns have prompted Apollo Care LLC, Columbia, Missouri, to recall nearly a dozen lots of vancomycin, according to the May 24, 2023, US Food and Drug Administration (FDA) Enforcement Report.

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

• vancomycin 750 mg added to 250 mL of 0.9% sodium chloride injection (NDC 71170-255-25) from lot AC-016632 (Exp. 5/24/23);
• vancomycin 1 g added to 250 mL of 0.9% sodium chloride injection (NDC 71170-254-25) from lots AC-016641 (Exp. 6/3/23) and AC-016653 (Exp. 7/26/23);
• vancomycin 1.25 g added to 250 mL of 0.9% sodium chloride injection (NDC 71170-264-25, NDC 71170-284-25) from lot AC-016647 (Exp. 6/28/23);
• vancomycin 1.5 g added to 250 mL of 0.9% sodium chloride injection (NDC 71170-184-25) from lots AC-016633 (Exp. 5/24/23) and AC-016651 (Exp. 7/22/23);
• vancomycin 1.5 g added to 500 mL of 0.9% sodium chloride injection (NDC 71170-185-50) from lots AC-016629 (Exp. 5/13/23) and AC-016646 (Exp. 6/24/23);
• vancomycin 1.75 g added to 500 mL of 0.9% sodium chloride injection (NDC 71170-194-50) from lot AC-016648 (Exp. 7/1/23);
• vancomycin 2 g added to 500 mL of 0.9% sodium chloride injection (NDC 71170-204-50) from lot AC-016638 (Exp. 5/27/23); and
• vancomycin 2.5 g added to 500 mL of 0.9% sodium chloride injection (NDC 71170-224-50) from lot AC-016649 (Exp. 7/1/23).

Apollo Care voluntarily initiated the recalls May 2, 2023. The FDA designated them Class II on May 18, 2023. The classification communicates use of the drug may cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.

Vancomycin injection is a prescription antibiotic used to treat serious bacterial infections.