October 2017 FDA Recall Drug by Genzyme Corporation
D-0075-2018 - Labeling

This Class III drug recall was voluntarily initiated by Genzyme Corporation on October 12, 2017 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0075-2018

Reason for Recall
Labeling: Incorrect or Missing Package Insert.
Initiated
10-12-2017
Reported
11-22-2017
Quantity
9,343 single dose vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78286
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Genzyme 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-10-2020
Product Description About Product Description
Full technical description of the product.
Clolar (clofarabine) 20 mg/20 mL (1 mg/mL) Injection, for intravenous use, Rx Only, Mfd. by: Teva Pharmachemie Swensweg 5 Haarlem, The Netherlands Mfd. for: Genzyme Corporation, Cambridge, MA 02142, NDC 0024-5860-01.

Batch or Lot Expiration Information

Lot# : K5006Y01; Exp. 08/31/18
Lot# : K5006Y03; Exp. 08/31/18
Lot# : K6001Y01; Exp. 03/31/19