Drug 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
D-1386-2019
Product summary
- Event
- Event 82915
- Status
- Terminated
- Classification
- Class III
- Quantity
- 11,981 units
- Official record key
drug-enforcement:D-1386-2019
Official wording
Reason: Failed Impurities/Degradation Specifications.
Code information: Lot #: 6018699, Exp. 12/2021
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications