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9/8/2016

Novo Nordisk Recalls Six Batches of GlucaGen HypoKit Because of Detached Needles

Cheryl Thompson

Cheryl A. ThompsonDirector
News Center

Novo Nordisk Inc. today announced a U.S. recall of six batches of the company's GlucaGen HypoKit glucagon for injection after two customers in other countries reported that the needle had detached from the kit's disposable prefilled syringe of sterile water.

The batches are FS6X270, FS6X296, FS6X538, FS6X597, FS6X797, and FS6X875. All 71,215 GlucaGen HypoKits in the six batches have an expiration date of September 30, 2017, and were distributed this year, the company said.

Novo Nordisk makes three types of GlucaGen products, two of which are for use only by healthcare providers.

The HypoKit is intended for use by patients and others to treat severe hypoglycemia. Each HypoKit has one 1-mg vial of glucagon for injection and one disposable syringe containing 1 mL of sterile water and an attached needle.

Novo Nordisk wants anyone with a GlucaGen HypoKit from one of the six batches under recall to call 888-840-1137 Monday to Friday, between 8:30 a.m. and 6 p.m. ET, for instructions on how to return the product. The company said it will reimburse purchasers' out-of-pocket cost for the product if proof of purchase is supplied. People who received their product through the Novo Nordisk Patient Assistance Program will receive a replacement.

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