FDA recall D-1386-2019
Fresenius Kabi USA, LLC · Class III · 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
Reason for recall
Failed Impurities/Degradation Specifications.
Distribution
Nationwide within the United States
Key facts
- Status
- Terminated
- Initiation date
- 2019-05-22
- Report date
- 2019-06-19
- Termination date
- 2021-01-28
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Grand Island, NY, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1386-2019