FDA recall D-0926-2016

Baptist Health Medical Towers Pharmacy and Infusion Services · Class II · drug

Product

Ertapenem 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR

Reason for recall

Lack of Sterility Assurance.

Distribution

Arkansas

Key facts

Status
Terminated
Initiation date
2016-04-18
Report date
2016-06-08
Termination date
2016-12-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Little Rock, AR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0926-2016