FDAFDA · Food and drugs·Recall number D-0146-2024
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
Published December 13, 2023 · Recall initiated: November 14, 2023
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed pH Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ONDANSETRON HYDROCHLORIDE
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- Nationwide in the USA
- UPC
- 0336000012256
- Lot
- Lot # A0E0959A, A0E0961A, A0E1015A, A0E1020A, Exp. Date 30-Nov-23; A0F0016A, Exp. Date 31-Dec-23; A0F0260A, A0F0261A, A0F0262A, Exp. Date 29-Feb-24; A0F0414A, A0F0415A, A0F0416A, A0F0417A, A0F0418A, Exp. Date 30-Apr-24; A0F0503A, Exp. Date 31-May-24, A0F0533A, A0F0534A, A0F0535A, A0F0536A, A0F0537A, A0F0540A, A0F0541A, Exp. Date 30-Jun-24; A0F0573A, A0F0574A, A0F0575A, A0F0592A, Exp. Date 31-Jul-24; A0F0596A, A0F0599A, Exp. Date 31-Aug-24 ; A0F0676A, 31-Oct-24.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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