Antiemetic Injection Pulled

More than 6 million vials of ondansetron injection distributed by Baxter Healthcare Corporation are under recall due to failing to meet pH specifications, according to the December 13, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects ondansetron injection, 4 mg/2 mL (2 mg/mL), 2 mL per vial (NDC 36000-012-25), from lots A0E0959A, A0E0961A, A0E1015A, and A0E1020A (Exp. 11/30/23); A0F0016A (Exp. 12/31/23); A0F0260A, A0F0261A, and A0F0262A (Exp. 2/29/24); A0F0414A, A0F0415A, A0F0416A, A0F0417A, and A0F0418A (Exp. 4/30/24); A0F0503A (Exp. 5/31/24); A0F0533A, A0F0534A, A0F0535A, A0F0536A, A0F0537A, A0F0540A, and A0F0541A (Exp. 6/30/24); A0F0573A, A0F0574A, A0F0575A, and A0F0592A (Exp. 7/31/24); A0F0596A and A0F0599A (Exp. 8/31/24); and A0F0676A (Exp. 10/31/24).

The product was manufactured by Baxter Pharmaceuticals, Ahmedabad, India, for Baxter Healthcare Corporation, Deerfield, Illinois, and distributed throughout the US.

Baxter Healthcare Corporation voluntarily initiated the recall on November 14, 2023. The FDA designated the recall Class II on December 7, 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.

Ondansetron is a prescription drug indicated for the prevention of nausea and vomiting associated with chemotherapy or after surgery.