Recalls / Class II
Class IID-0146-2024
Product
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
- Brand name
- Ondansetron Hydrochloride
- Generic name
- Ondansetron Hydrochloride
- Active ingredient
- Ondansetron Hydrochloride
- Route
- Intramuscular, Intravenous
- NDCs
- 36000-012, 36000-013
- FDA application
- ANDA078287
- Affected lot / code 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.
Why it was recalled
Failed pH Specifications
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 6,022,675 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-11-14
- FDA classified
- 2023-12-07
- Posted by FDA
- 2023-12-13
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0146-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.