GlucaGen HypoKit Voluntarily Recalled by Novo Nordisk
By Lynn Kennedy and Kelly Close
Six batches recalled in the US on Sept. 9, 2016 due to small chance of detached needles within the kit
Novo Nordisk voluntarily recalled six batches of its GlucaGen HypoKit (glucagon for injection) on September 9, 2016. Two reports out of Europe detailed malfunction of needles on the syringe containing Sterile Water for Injection (SWFI) – an essential component of the kit. While the chances of a detached needle in any given kit are small (it is estimated that 4 of 71,215 recalled pens won’t work), Novo Nordisk is working with the FDA to quickly recall all affected kits, including those already purchased.
Only GlucaGen HypoKits purchased after February 15, 2016 may be subject to the current product recall. To determine whether a kit is affected, check the batch number and expiry date (see photo). Batches FS6X270, FS6X296, FS6X538, FS6X597, FS6X797, and FS6X875, all with an expiry of 09/30/2017, should be returned to Novo Nordisk. Call 1-888-840-1137 Monday to Friday, 8:30-6:00 PM Eastern Time, for more details about product return. Any out-of-pocket costs will be reimbursed with proof of purchase; kits received through the Novo Nordisk Patient Assistance Program will be replaced.
Glucagon is a potentially life-saving medication for people with diabetes using insulin who experience severe hypoglycemia (low blood sugar). In its earlier stages, hypoglycemia is recognizable by low blood glucose readings, shakiness, dizziness, sweating, hunger, irritability or moodiness, anxiety or nervousness, and headache. Left untreated, it may cause unconsciousness, seizures, coma, or death, making prompt recognition and treatment critical.
Broadly speaking, there remains much room for innovation in glucagon products, and especially with regards to improvements aimed at making glucagon easier to use. A number of other companies working on this include Lilly Diabetes (Locemia), Zealand, Xeris, Biodel, Zosano Pharma, Latitude, Enject, and Arecor. Although glucagon products haven’t advanced as fast as desired, Novo Nordisk’s timely reaction to the reported needle malfunctions certainly reflects much-appreciated commitments to quality and safety – key attributes in both drug and device manufacturing.
For more information on this product recall and the GlucaGen HypoKit, read Novo Nordisk’s press release here.
[Photo Credit: Novo Nordisk]