Ondansetron Injection recall: Impurity Out of Spec
Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20
Why was Ondansetron Injection recalled?
Failed Impurities/Degradation Specifications.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 6018699, Exp. 12/2021
- Product
- Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 11,981 units
- Distribution
- Nationwide within the United States
- Recall date
- June 19, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)