D-1029-2016 Class III Terminated
FDA drug recall D-1029-2016 was initiated by Genzyme Corporation / Genzyme Biosurgery on April 27, 2016 and is designated Class III. Reason for recall: Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial. The recall status is terminated (terminated June 23, 2017). Affected quantity: 2350 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- June 22, 2016
- Initiation Date
- April 27, 2016
- Termination Date
- June 23, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2350 vials
Product Description
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 Pattern
MI, PA & NJ
Code Information
Lot #: 6R1001, Exp. 12/2016