Recall Enforment Report D-0146-2024
Recall Details
Drug Recall Enforcement Report Class II voluntary initiated by Baxter Healthcare Corporation, originally initiated on 11-14-2023 for the 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 The product was recalled due to failed ph specifications. The product was distributed nationwide and the recall is currently ongoing.
Recalled Products
NDC | Proprietary Name | Non-Proprietary Name | Dosage Form | Route Name | Company Name | Product Type |
---|---|---|---|---|---|---|
36000-012 | Ondansetron Hydrochloride | Ondansetron Hydrochloride | Solution | Intramuscular; Intravenous | Baxter Healthcare Corporation | Human Prescription Drug |