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Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter...

FDA Recall #D-0573-2018 — Class I — November 10, 2017

Recall #D-0573-2018 Date: November 10, 2017 Classification: Class I Status: Terminated

Product Description

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

Recalling Firm

Baxter Healthcare Corporation — Deerfield, IL

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

35,628 single-dose containers

Distribution

Nationwide within USA and Puerto Rico

Code Information

Lot #, Expiry: NC109925, Exp 6/1/2019; NC109123, 5/2019

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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