FDA Recall Nexterone

The most recent Recall Enforcement Report that covers this product was initiated on November 10th, 2017 and classified as a Class I recall due to 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 recall is currently terminated, and the associated recall number is recall number is D-0573-2018. It pertains to Nexterone identified by 43066-360 as of 08-29-2018 .

Recall Number D-0573-2018

Event ID

78531 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).

Recall Number

D-0573-2018 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).

Recall Classification

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. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".

Distribution Pattern

Nationwide within USA and Puerto Rico What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.

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 What is the Reason for Recall?
Information describing how the product is defective.

Product Quantity

35,628 single-dose containers Product Quantity
The amount of product subject to recall.

Voluntary Mandated

Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.

Report Date

02-07-2018

Recall Initiation Date

11-10-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.

Termination Date

08-29-2018 What is the Date Terminated?
The date that FDA terminated the recall.

Initial Firm Notification

Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.

Product Type

Drugs

Recalling Firm

Baxter Healthcare Corporation

Code Info/dt>

Lot #, Expiry: NC109925, Exp 6/1/2019; NC109123, 5/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.

Recalled NDC Packages

43066-150-10; 43066-360-20

Status

Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

View Recall Report

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.