Drug Safety Alerts

Glucagen® Hypokit® for Injection Patient-Level Recall

09/08/2016

On September 8, 2016, Novo Nordisk issued a patient-level recall of Glucagen^® Hypokit^® for Injection. This recall was issued because a small number of needles were detached from the syringe. A syringe with a detached needle cannot be used as prescribed.

Novo Nordisk conducted an investigation which showed that a small number (0.006%) of needles could be detached from the syringe in certain batches of GlucaGen^® HypoKit^®. To protect patient safety, Novo Nordisk is recalling affected batches from wholesalers, pharmacies and patients in the United States.  It is estimated that out of the 71,215 pens being recalled, four pens could be defective.

This recall includes GlucaGen HypoKit lot numbers:

• FS6X270, Exp. 09/30/2017

• FS6X296, Exp. 09/30/2017

• FS6X538, Exp. 09/30/2017

• FS6X597, Exp. 09/30/2017

• FS6X797, Exp. 09/30/2017

• FS6X875, Exp. 09/30/2017

The affected products were distributed starting February 15, 2016.

Novo Nordisk is working as quickly as possible and in collaboration with the U.S. Food and Drug Administration (FDA) to recall affected products from the marketplace, including those in the possession of patients. To date, Novo Nordisk is not aware of any known adverse events resulting from the use of the recalled batches.

To protect patient safety, Novo Nordisk is recalling all products from the affected lots from wholesalers, pharmacies and patients in the United States.

CVS Caremark Response: Because of this action, CVS Caremark is sending letters to members who received this product through CVS Caremark Mail Service Pharmacy and their physicians.

For more information, health care providers may contact Novo Nordisk at1-800-727-6500 or visit http://press.novonordisk-us.com.

You may also call the United States Food and Drug Administration at 1‑888‑INFO-FDA (1‑888‑463‑6332) or visit their web site at http://www.fda.gov.