GlucaGen HypoKit (glucagon [rDNA origin] for injection) by Novo Nordisk Inc: Recall - Detached Needles on Syringe

AUDIENCE: Pharmacy, Patient

ISSUE: Novo Nordisk Inc. is recalling six batches of the GlucaGen HypoKit in the U.S. due to two customer complaints from the UK and Portugal involving detached needles on the syringe with Sterile Water for Injection (SWFI). A syringe with a detached needle cannot be used as prescribed. Untreated hypoglycemia can eventually lead to unconsciousness and seizures, which can prove fatal. If the blood glucose levels are not quickly restored, continuing hypoglycemia can lead to a decline in brain glucose levels which manifests through a variety of symptoms including cognitive dysfunction, sweating, tremors, convulsion and eventually coma or death.

This recall includes GlucaGen HypoKit batch numbers:

Batch: FS6X270, Expiry: 09/30/2017
Batch: FS6X296, Expiry: 09/30/2017
Batch: FS6X538, Expiry: 09/30/2017
Batch: FS6X597, Expiry: 09/30/2017
Batch: FS6X797, Expiry: 09/30/2017
Batch: FS6X875, Expiry: 09/30/2017

BACKGROUND: GlucaGen HypoKit is indicated for the treatment of severe hypoglycemia (low blood sugar) in patients with diabetes who are treated with insulin. 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. It is estimated that out of the 71,215 pens being recalled, four pens could be defective. The affected products were distributed starting February 15, 2016.

RECOMMENDATION: Patients or caregivers should check the batch number to see if their GlucaGen HypoKit is affected. The batch number is printed on the GlucaGen HypoKit as indicated in the product photos in thepress release.

If you have a GlucaGen HypoKit with one of the affected batch numbers, call 1-888-840-1137 from Monday to Friday, between 8:30am - 6:00pm Eastern Time, to find out how to return the product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm519907.htm