Class II · Moderate risk
Glucagon Emergency Kit for Low Blood Sugar
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
GlucaGen HypoKit
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Defective delivery system: detached needles on the syringe in the kit.
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
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
Affected NDC
0169-7065-15
Compare with the code on your package — it is the most precise check available.
Drug: Glucagon
- Recalling firm
- Novo Nordisk Inc
- NDC code
- 0169-7065-15
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0217-2017 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Glucagon recalls
See all
Class II · Moderate risk
Glucagon Emergency Kit for Low Blood Sugar
cGMP deviations: Temperature abuse
Class II · Moderate risk
Glucagen (glucagon)
cGMP deviations: Temperature abuse
Class II · Moderate risk
GlucaGen (glucagon)
cGMP deviations: Temperature abuse
Class I · High risk
Glucagon Emergency Kit for Low Blood Sugar
SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
Other recalls by Novo Nordisk Inc
All 2016 recalls
Class II · Moderate risk
Wegovy (semaglutide)
Presence of Particulate Matter: Hair was found in a prefilled syringe
Class II · Moderate risk
Wegovy (semaglutide)
Presence of Particulate Matter: Hair was found in a prefilled syringe
Class I · High risk
Xultophy 100/3.6
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Class II · Moderate risk
ViCTOZA (liraglutide)
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
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