FDA recall D-1029-2016

Product

Hectorol (doxercalciferol injection) 2 mcg/1mL, Rx only, Manufactured by: Genzyme Biosurgery Corporation 500 Kendall Street, Cambridge, MA 02142, NDC 58468-0126-1

Reason for recall

Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.

Distribution

MI, PA & NJ

Key facts

Status

Terminated

Initiation date

2016-04-27

Report date

2016-06-22

Termination date

2017-06-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ridgefield, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1029-2016