sábado, 10 de septiembre de 2016

Novo Nordisk Inc. issues voluntary nationwide recall of six batches of GlucaGen® HypoKit® (glucagon [rDNA origin] for injection) due to detached needles on the syringe in the kit




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.
For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.

Helene D. Clayton-Jeter, O.D.
Office of Health and Constituent Affairs
Food and Drug Administration
For more information about the Cardiovascular & Endocrine Liaison Program visit the FDA Patient Network

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