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
Reported: December 13, 2023 Initiated: November 14, 2023 #D-0146-2024
Product Description
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
Reason for Recall
Failed pH Specifications
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 6,022,675 vials
- Distribution
- Nationwide in the USA
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Baxter Healthcare Corporation. Units affected: 6,022,675 vials.
Why was this product recalled? ▼
Failed pH Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 13, 2023. Severity: Moderate. Recall number: D-0146-2024.
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