Recall of GlucaGen HypoKit 1 mg/ml - Powder and solvent for solution for injection

Safety warnings | Medicines | 06/09/2016

GlucaGen HypoKit 1 mg/ml - powder and solvent for solution for injection (glucagon hydrochloride) is approved in Austria for the treatment of severe hypoglycemic reactions that may occur during insulin therapy in children and adults with diabetes mellitus.

Novo Nordisk received two customer complaints regarding GlucaGen HypoKit, reporting needle detachment from the pre-filled syringe with sterile water for injection. An investigation conducted by Novo Nordisk found that a very small number of needles (0.006%) were detached from syringes in certain lots of GlucaGen HypoKit. A GlucaGen HypoKit with a detached needle cannot be used as prescribed in the event of a hypoglycemic episode, therefore 55 batches are being recalled worldwide.

In Austria, the batch with batch number FS6X569 is affected.

Measures at EU level

A recall of risk class 1 down to patient level has been initiated (http://www.ema.europa.eu, Compilation of Community Procedures on Inspections and Exchange of Information).

Situation in Austria The following affected drug product is approved in Austria: GlucaGen HypoKit 1 mg/ml - powder and solvent for the preparation of a solution for injection The BASG has not received any notification from Austria concerning this product from the period in question.

BASG recommendations Recommendations for healthcare professionals:

Please inform your patients using GlucaGen HypoKit about this problem. Urge patients to return their GlucaGen HypoKit with lot number FS6X569 to their pharmacy. Novo Nordisk will provide a replacement free of charge.
Please report any suspected adverse reaction related to this quality defect via the national reporting system: Bundesamt für Sicherheit im Gesundheitswesen Traisengasse 5, 1200 Vienna Fax: + 43 (0) 50 555 36207 Website: http: //www.basg.gv.at/

Recommendations for patients:

Please bring your GlucaGen HypoKit with lot number FS6X569 to your pharmacy immediately. Novo Nordisk will provide a free replacement upon return of the product with the affected lot number through pharmacies.