Baxter Healthcare Corporation recalls Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation…

Recall date

November 10, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0573-2018

FDA classification

Class I

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

Nationwide within USA and Puerto Rico

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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