FDA-Drug2023-12-13Class II

Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Manufactured by: Baxter Pharmaceuticals India Private Ltd, Ahmedabad 382213, India. NDC 36000-012-25

Baxter Healthcare Corporation
Hazard

Failed pH Specifications

Sold states
Nationwide in the USA
Affected count
6,022,675 vials
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Manufactured by: Baxter Pharmaceuticals India Private Ltd, Ahmedabad 382213, India. NDC 36000-012-25

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0146-2024

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