FDA recall D-0573-2018

Product

Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10

Reason for recall

Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged

Distribution

Nationwide within USA and Puerto Rico

Key facts

Status

Terminated

Initiation date

2017-11-10

Report date

2018-02-07

Termination date

2018-08-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0573-2018