Why it was recalled
Defective delivery system: detached needles on the syringe in the kit.
Product description
GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Single use only, Rx Only, Manufactured by: Novo Nordisk A/S 2880 Bagsvaerd, Denmark, NDC 0169-7065-15
Lot numbers, UPCs & expiration codes
Lots: FS6X270, FS6X296, FS6X538, FS6X597, FS6X797, FS6X875; Exp 9/30/2017
Where it was sold
Nationwide and Worldwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0217-2017
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 8, 2016
- FDA report date
- Dec 28, 2016
- Quantity
- 71,215 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novo Nordisk Inc
Original FDA data
Every field from FDA enforcement report D-0217-2017, exactly as published.
Show all FDA fields
- City
- Plainsboro
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 75123
- Address
- 800 Scudders Mill Road
- Code information
- Lots: FS6X270, FS6X296, FS6X538, FS6X597, FS6X797, FS6X875; Exp 9/30/2017
- Postal code
- 08536
- Report date
- Dec 28, 2016
- Product type
- Drugs
- Recall number
- D-0217-2017
- Classification
- Class I
- Recalling firm
- Novo Nordisk Inc
- Product quantity
- 71,215 kits
- Termination date
- Feb 27, 2018
- Reason for recall
- Defective delivery system: detached needles on the syringe in the kit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Single use only, Rx Only, Manufactured by: Novo Nordisk A/S 2880 Bagsvaerd, Denmark, NDC 0169-7065-15
- Distribution pattern
- Nationwide and Worldwide
- Recall initiation date
- Sep 8, 2016
- Initial firm notification
- Press Release
- Center classification date
- Dec 22, 2016