FDA recall D-0896-2021
IntegraDose Compounding Services LLC · Class II · drug
Product
ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-7087-1
Reason for recall
Lack of sterility assurance.
Distribution
NH, MA, MN
Key facts
- Status
- Terminated
- Initiation date
- 2021-09-17
- Report date
- 2021-10-06
- Termination date
- 2022-10-02
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Minneapolis, MN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0896-2021