Status
Completed
Drug Enforcement D-0146-2024
Failed pH Specifications
Classification
Class II
Report Date
December 13, 2023
Termination Date
—
Product Information
- 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
- Product quantity
- 6,022,675 vials
- Reason for recall
- Failed pH Specifications
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Baxter Healthcare Corporation
- Address
-
1 Baxter Pkwy
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0146-2024
- Event ID
- 93359
- Recall initiation date
- November 14, 2023
- Center classification date
- December 7, 2023
- 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.
- More code info
- —