Recalls / Class I
Class ID-0217-2017
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Affected lot / code info
- Lots: FS6X270, FS6X296, FS6X538, FS6X597, FS6X797, FS6X875; Exp 9/30/2017
Why it was recalled
Defective delivery system: detached needles on the syringe in the kit.
Recalling firm
- Firm
- Novo Nordisk Inc
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 800 Scudders Mill Road, N/A, Plainsboro, New Jersey 08536
Distribution
- Quantity
- 71,215 kits
- Distribution pattern
- Nationwide and Worldwide
Timeline
- Recall initiated
- 2016-09-08
- FDA classified
- 2016-12-22
- Posted by FDA
- 2016-12-28
- Terminated
- 2018-02-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0217-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.