Novo Nordisk Recalls GlucaGen HypoKits Due to Detached Needles
Novo Nordisk is recalling 71,215 GlucaGen HypoKits because the syringe needles may be detached. The recall covers lots expiring in September 2017.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Novo Nordisk Inc is recalling 71,215 units of GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial. The recall is due to a defective delivery system where the needles on the syringe in the kit may be detached.
The affected product is identified by NDC 0169-7065-15 and includes lots FS6X270, FS6X296, FS6X538, FS6X597, FS6X797, and FS6X875, all with an expiration date of 9/30/2017. The product was distributed nationwide and worldwide.
Consumers should stop using the affected kits and contact their healthcare provider or Novo Nordisk for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- 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
- Manufacturer
- Novo Nordisk Inc
- Category
- Drug — Injectable Medication
- Affected units
- 71,215
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lots: FS6X270
- FS6X296
- FS6X538
- FS6X597
- FS6X797
- FS6X875
- Exp 9/30/2017
Distribution
Distributed nationwide across the United States.
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