FDAnews Device Daily Bulletin

Novo Nordisk Recalls GlucaGen HypoKit Due to Detached Needles

Sept. 12, 2016

Novo Nordisk 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.

GlucaGen HypoKit is indicated for the treatment of severe hypoglycemia in patients with diabetes who are treated with insulin.

This recall includes GlucaGen® HypoKit® batch numbers: FS6X270, Expiry: 09/30/2017; FS6X296, Expiry: 09/30/2017; FS6X538, Expiry: 09/30/2017; FS6X597, Expiry: 09/30/2017; FS6X797, Expiry: 09/30/2017; FS6X875, Expiry: 09/30/2017. — Cynthia Jessup

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