The FDA has announced today that Novo Nordisk has made the decision to recall six batches of the glucagon-injecting devices after it has been reported that needles in the GlucaGen HypoKit have detached from the syringes.
A detachment of the needle was reported to Novo Nordisk by a customer in Portugal and one from the United Kingdom. Once detached, the syringe becomes unusable. Unmanaged or untreated hypoglycemia can lead to unconsciousness, seizures, and death. The company researched and found that out of 71,215 devices, only an estimated four would be at risk of detaching in the United States. This research includes kits distributed since February 15 of this year. The recall covers six batches with an expiration of September 30, 2017.
While it can be extremely costly for a manufacturer to do a product recall, it is pertinent to the consumers’ health and safety. GlucaGen HypoKit is approved and is used in treating those with hypoglycemia, an abnormal decrease in the blood sugar. Unmanaged or untreated hypoglycemia can lead to unconsciousness, seizures, and death.
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