Medications & Supplements/Prescription Drugs

Baxter Ondansetron Injection Recalled for Failed pH Specifications

Agency Publication Date: December 7, 2023

Summary

Baxter Healthcare Corporation is recalling 6,022,675 vials of Ondansetron (ondansetron) Injection, USP, 4 mg/2 mL (2 mg/mL). The recall was initiated because the product failed pH specifications, meaning the acidity level is outside the required range for this medication. Using an injectable drug with an improper pH level could result in reduced effectiveness of the treatment or cause physical irritation and pain at the site of injection.

Risk

Injectable medications with incorrect pH levels can cause localized tissue damage or reduced stability of the active ingredient. While no incidents or injuries have been reported, the failure to meet quality standards poses a moderate risk to patient safety during administration.

What You Should Do

This recall involves 2 mL vials of Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL) manufactured for Baxter Healthcare Corporation with NDC 36000-012-25.
Identify if your stock is affected by checking the lot number and expiration date printed on the vial or carton. See the Affected Products section below for the full list of affected codes.
Stop using the recalled product immediately and quarantine all affected stock to prevent further use.
Contact Baxter Healthcare Corporation or your authorized distributor to arrange for the return of any unused recalled vials.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

Other Action

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial

Variants: 4 mg/2 mL (2 mg/mL), 2 mL vial, Rx only

Lot Numbers:

A0E0959A (Exp. 30-Nov-23)

A0E0961A (Exp. 30-Nov-23)

A0E1015A (Exp. 30-Nov-23)

A0E1020A (Exp. 30-Nov-23)

A0F0016A (Exp. 31-Dec-23)

A0F0260A (Exp. 29-Feb-24)

A0F0261A (Exp. 29-Feb-24)

A0F0262A (Exp. 29-Feb-24)

A0F0414A (Exp. 30-Apr-24)

A0F0415A (Exp. 30-Apr-24)

A0F0416A (Exp. 30-Apr-24)

A0F0417A (Exp. 30-Apr-24)

A0F0418A (Exp. 30-Apr-24)

A0F0503A (Exp. 31-May-24)

A0F0533A (Exp. 30-Jun-24)

A0F0534A (Exp. 30-Jun-24)

A0F0535A (Exp. 30-Jun-24)

A0F0536A (Exp. 30-Jun-24)

A0F0537A (Exp. 30-Jun-24)

A0F0540A (Exp. 30-Jun-24)

A0F0541A (Exp. 30-Jun-24)

A0F0573A (Exp. 31-Jul-24)

A0F0574A (Exp. 31-Jul-24)

A0F0575A (Exp. 31-Jul-24)

A0F0592A (Exp. 31-Jul-24)

A0F0596A (Exp. 31-Aug-24)

A0F0599A (Exp. 31-Aug-24)

A0F0676A (Exp. 31-Oct-24)

NDC:

36000-012-25

Manufactured by Baxter Pharmaceuticals India Private Ltd for Baxter Healthcare Corporation.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93359

Status: Resolved

Manufacturer: Baxter Healthcare Corporation

Sold By: Hospitals; Clinics; Pharmacies

Manufactured In: United States, India

Units Affected: 6,022,675 vials

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall involves 2 mL vials of Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL) manufactured for Baxter Healthcare Corporation with NDC 36000-012-25.

Identify if your stock is affected by checking the lot number and expiration date printed on the vial or carton. See the Affected Products section below for the full list of affected codes.

Stop using the recalled product immediately and quarantine all affected stock to prevent further use.

Contact Baxter Healthcare Corporation or your authorized distributor to arrange for the return of any unused recalled vials.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Affected Products

Product: Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL per vial

Variants: 4 mg/2 mL (2 mg/mL), 2 mL vial, Rx only

Lot Numbers:

A0E0959A (Exp. 30-Nov-23)

A0E0961A (Exp. 30-Nov-23)

A0E1015A (Exp. 30-Nov-23)

A0E1020A (Exp. 30-Nov-23)

A0F0016A (Exp. 31-Dec-23)

A0F0260A (Exp. 29-Feb-24)

A0F0261A (Exp. 29-Feb-24)

A0F0262A (Exp. 29-Feb-24)

A0F0414A (Exp. 30-Apr-24)

A0F0415A (Exp. 30-Apr-24)

A0F0416A (Exp. 30-Apr-24)

A0F0417A (Exp. 30-Apr-24)

A0F0418A (Exp. 30-Apr-24)

A0F0503A (Exp. 31-May-24)

A0F0533A (Exp. 30-Jun-24)

A0F0534A (Exp. 30-Jun-24)

A0F0535A (Exp. 30-Jun-24)

A0F0536A (Exp. 30-Jun-24)

A0F0537A (Exp. 30-Jun-24)

A0F0540A (Exp. 30-Jun-24)

A0F0541A (Exp. 30-Jun-24)

A0F0573A (Exp. 31-Jul-24)

A0F0574A (Exp. 31-Jul-24)

A0F0575A (Exp. 31-Jul-24)

A0F0592A (Exp. 31-Jul-24)

A0F0596A (Exp. 31-Aug-24)

A0F0599A (Exp. 31-Aug-24)

A0F0676A (Exp. 31-Oct-24)

NDC:

36000-012-25

Manufactured by Baxter Pharmaceuticals India Private Ltd for Baxter Healthcare Corporation.