FDA recall D-0678-2020
Assurance Infusion · Class II · drug
Product
Bi-Mix Forte 30 mg/2 mg/mL Inj. in 1 mL vials Assurance Infusion (713) 533-8800
Reason for recall
Lack of sterility assurance.
Distribution
Nationwide within the United States
Key facts
- Status
- Terminated
- Initiation date
- 2019-12-20
- Report date
- 2020-01-22
- Termination date
- 2021-10-27
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Houston, TX, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0678-2020