Nexterone Injection, Solution
FDA Recall NDC 43066-360
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Nexterone (NDC 43066-360). A significant event, classified as Class I, was initiated on Nov 10, 2017 by Baxter Healthcare Company. The reported reason for this action was: "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"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
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
Nov 10, 2017
Feb 07, 2018
35,628 single-dose containers
Recall Profile & Regulatory Data
Event ID
78531
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within USA and Puerto Rico
Termination Date
Aug 29, 2018
Product Description
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
43066-150-10Product
43066-360-20Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
