Recalls / Class III
Class IIID-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
- Affected lot / code info
- Lot #: 6R1001, Exp. 12/2016
Why it was recalled
Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.
Recalling firm
- Firm
- Genzyme Corporation / Genzyme Biosurgery
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1125 Pleasantview Ter, Ridgefield, New Jersey 07657-2310
Distribution
- Quantity
- 2350 vials
- Distribution pattern
- MI, PA & NJ
Timeline
- Recall initiated
- 2016-04-27
- FDA classified
- 2016-06-10
- Posted by FDA
- 2016-06-22
- Terminated
- 2017-06-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1029-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.