November 2017 FDA Recall Nexterone by Baxter Healthcare Corporation
D-0573-2018 - Presence of Particulate Matter

This Class I drug recall was voluntarily initiated by Baxter Healthcare Corporation on November 10, 2017 for the product Nexterone. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0573-2018

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
Initiated
11-10-2017
Reported
02-07-2018
Quantity
35,628 single-dose containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78531
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Baxter Healthcare Corporation
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within USA and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-29-2018
Product Description About Product Description
Full technical description of the product.
Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

43066-150-10 Nexterone
43066-360-20 Nexterone