
Novo Nordisk Recalls GlucaGen HypoKit
The company voluntarily recalled the product due to detached needles on the syringe in the kit.
On Sept. 8, 2016, Novo Nordisk
The customer complaints came from the United Kingdom and Portugal and involved detached needles on the syringe with Sterile Water for Injection (SWFI), rendering the product unable to be used as prescribed. A company investigation found that a small number of needles could be detached from the syringe in certain batches. The batches are being recalled to product patient safety, and the company estimates that 4 out of 71,215 pens may be defective. The recalled batch numbers are as follows:
- 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
According to Novo Nordisk, GlucaGen HypoKit is used for the treatment of severe hypoglycemia (low blood sugar) in patients with diabetes who are treated with insulin. If left untreated, hypoglycemia can lead to unconsciousness and seizures as well as a decline in brain glucose levels. A decline in brain glucose can cause cognitive dysfunction, sweating, tremors, convulsion, and eventually coma or death.
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