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). GlucaGen® HypoKit® is indicated for the treatment of severe hypoglycemia (low blood sugar) in patients with diabetes who are treated with insulin. A syringe with a detached needle cannot be used as prescribed.
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The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.
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