FDA recall D-0775-2020

Assurance Infusion · Class II · drug

Product

TRIMIX -A (UA) 30MG/1MG/5 MCG/ML INJ in 1 mL vial 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-0775-2020