← FDA ENFORCEMENT
D-0146-2024Class II

Baxter Healthcare Corporation

Recalling firm
Baxter Healthcare Corporation
Product type
Drug
Status
Completed
Report date
2023-12-13
Distribution
Nationwide in the USA
Firm state
IL
Product quantity
6,022,675 vials
Initiated by
Voluntary: Firm initiated
Reason for recall

Failed pH Specifications

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

Code / lot info

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.

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.