GlucaGen HypoKit Glucagon Recall [US]


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US/Silver Spring: 7565-glucagenhypokitglucagonNovo Nordisk Inc. recalls certain batch/lots of GlucaGen HypoKit Glucagon due to suspected needle detachment and consequential operational failure and injury hazards. FDA: http://ht.ly/ZLWz3046mE7

Direct link: http://www.fda.gov/Safety/Recalls/ucm519872.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following HypoKits are subject to this recall:

  • GlucaGen HypoKit, batch number: FS6X270, expiry date: 09/30/2017
  • GlucaGen HypoKit, batch number: FS6X296, expiry date: 09/30/2017
  • GlucaGen HypoKit, batch number: FS6X538, expiry date: 09/30/2017
  • GlucaGen HypoKit, batch number: FS6X597, expiry date: 09/30/2017
  • GlucaGen HypoKit, batch number: FS6X797, expiry date: 09/30/2017
  • GlucaGen HypoKit, batch number: FS6X875, expiry date: 09/30/2017

Please consult the photograph above for details of the drug’s packaging, design and retail presentation.

According to the FDA, Novo Nordisk reports a small number (estimated at 0.006%) of Needles could be detached from the Syringe in certain batches of GlucaGen HypoKits. If detachment of the injection needle from the pre-filled solvent syringe does occur, it would prevent injection of the medicine and possibly cause injury.

If you believe you have purchased or have in your possession any of the recalled GlucaGen HypoKit Glucagon, please do not use them. Instead, kindly call 1-888-840-1137 from Monday to Friday, between 8:30 AM to 6:00 PM Eastern Time, to find out how to return the product.

Novo Nordisk will also provide reimbursement for out-of-pocket costs incurred for the purchase for your affected GlucaGen HypoKit with proof of purchase. If you received a GlucaGen HypoKit through the Novo Nordisk Patient Assistance Program, you will receive a replacement device.

Please note: a similar product has been recalled in another jurisdiction, specifically Australia. To see all notifications related to this recall, please search for “Novo Nordisk” using the Search Box at the top of this page.

Want to read more about this recall? Please click on the links above to visit the originating site.

Want to read more about other recalls? Please click on the links below.

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Additional information about this recall:
Recalls Direct RIN: 7565-2016
More recalls? Back to the main Recalls Direct page: http://www.RecallsDirect.com/
About the Recalls Direct service: http://wp.me/P2bVty-2
Visit the Living Safely site: http://www.LivingSafely.org/
E. & O. E.

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