About 11,981 units of Ondansetron Injection, USP (40 mg / 20 mL) in 20 mL vials are being recalled because the medication failed to meet required impurity and degradation specifications. Ondansetron is a prescription drug commonly used to prevent nausea and vomiting. While the risk is considered low, using a medication with excessive impurities or degradation can impact the drug's safety and effectiveness. Consumers who have this product should contact their healthcare provider or pharmacist for guidance and instructions on returning any unused medication.
The drug failed testing for impurities and degradation, which means the chemical composition of the medication has changed beyond approved safety levels. Using medication that has degraded can lead to reduced treatment efficacy or unexpected side effects from the breakdown of the active ingredients.
Contact healthcare provider and return for refund.
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Sources: FDA iRES · Raw API Response
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