Reported Dec 13, 2023 · Completed

Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial, Rx only, Manufactured for: Baxter Healthcare…

Baxter Healthcare Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Baxter Healthcare Corporation · 1 Baxter Pkwy · Deerfield, IL · 60015-4625

Is this the product you have?

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

8 of 8 products

Products covered by this recall
#Product as published
1Lot # A0E0959A, A0E0961A, A0E1015A, A0E1020A, Exp. Date 30-Nov-23
2A0F0016A, Exp. Date 31-Dec-23
3A0F0260A, A0F0261A, A0F0262A, Exp. Date 29-Feb-24
4A0F0414A, A0F0415A, A0F0416A, A0F0417A, A0F0418A, Exp. Date 30-Apr-24
5A0F0503A, Exp. Date 31-May-24, A0F0533A, A0F0534A, A0F0535A, A0F0536A, A0F0537A, A0F0540A, A0F0541A, Exp. Date 30-Jun-24
6A0F0573A, A0F0574A, A0F0575A, A0F0592A, Exp. Date 31-Jul-24
7A0F0596A, A0F0599A, Exp. Date 31-Aug-24
8A0F0676A, 31-Oct-24.
Amount recalled
6,022,675 vials

Where it was sold

  • Nationwide

Why it was recalled

Failed pH Specifications

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 7:59 PM UTC

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