FDA recall D-0666-2020
Assurance Infusion · Class II · drug
Product
BAC 160MCG/HYDROM 16MG/ML INJ in 20 mL syringe 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-0666-2020