FDA recall D-0897-2021
IntegraDose Compounding Services LLC · Class II · drug
Product
ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC: 71139-7153-1
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-0897-2021