April 2016 FDA Recall Drug by Genzyme Corporation / Genzyme Biosurgery
D-1029-2016 - Labeling

This Class III drug recall was voluntarily initiated by Genzyme Corporation / Genzyme Biosurgery on April 27, 2016 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in MI, PA & NJ and the recall is currently terminated.

Recall Number: D-1029-2016

Reason for Recall
Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.
Initiated
04-27-2016
Reported
06-22-2016
Quantity
2350 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
74046
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 / Genzyme Biosurgery
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.
MI, PA & NJ
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-23-2017
Product Description About Product Description
Full technical description of the product.
Hectorol (doxercalciferol injection) 2 mcg/1mL, Rx only, Manufactured by: Genzyme Biosurgery Corporation 500 Kendall Street, Cambridge, MA 02142, NDC 58468-0126-1

Batch or Lot Expiration Information

Lot# : 6R1001, Exp. 12/2016