FDA Recall Paclitaxel

The most recent Recall Enforcement Report that covers this product was initiated on June 27th, 2012 and classified as a Class II recall due to the affected lots of carboplatin injection, cytarabine injection, methotrexate injection, usp, and paclitaxel injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. there may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution. This recall is currently terminated, and the associated recall number is recall number is D-1682-2012. It pertains to Paclitaxel identified by 61703-342 as of 12-15-2016 .

Recall Number D-1682-2012

Event ID

62459 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).

Recall Number

D-1682-2012 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).

Recall Classification

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote 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, including Puerto Rico and Guam. Product was also distributed internationally to Australia, Belgium, Canada, France, Germany, Korea, Malaysia, New Zealand, Norway, Pakistan, Philippines, Portugal, Singapore, Sweden, Thailand and Vietnam 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

Paclitaxel Injection, 6 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; N DC 61703-342-50

Reason For Recall

The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution. What is the Reason for Recall?
Information describing how the product is defective.

Product Quantity

131,264 vials 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

09-26-2012

Recall Initiation Date

06-27-2012 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.

Termination Date

12-15-2016 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

Hospira Inc.

Code Info/dt>

lot numbers Y096865AA, exp AUG 2013; Y106865AA, exp AUG 2013; Y116865AA, exp AUG 2013; Y126865AA, exp SEP 2013; Y136865AA, exp SEP 2013; Y146865AA, exp SEP 2013; Y156865AA, exp OCT 2013; Y166865AA, exp NOV 2013; Y176865AA, exp NOV 2013; and Y186865AA, exp DEC 2013 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

61703-342-09; 61703-342-22; 61703-342-50; 61703-015-04

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.