FDA-Drug2018-02-07Class I

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

Baxter Healthcare Corporation
Hazard

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

Sold states
Nationwide within USA and Puerto Rico
Affected count
35,628 single-dose containers
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10

Official notice

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

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