Drug product
Hectorol (doxercalciferol injection) 2 mcg/1mL, Rx only, Manufactured by: Genzyme Biosurgery Corporation 500 Kendall Street, Cambridge, MA 02142, NDC 58468-0126-1
D-1029-2016
Product summary
- Event
- Event 74046
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2350 vials
- Official record key
drug-enforcement:D-1029-2016
Official wording
Reason: Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.
Code information: Lot #: 6R1001, Exp. 12/2016
Distribution pattern: MI, PA & NJ
Derived failure modes
-
Labeling or packaging
Labeling: Wrong barcode. An incorrect