Class I — High risk. Reasonable probability of serious harm or death.
Defective delivery system: detached needles on the syringe in the kit.
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Reason cGMP deviations: Temperature abuse
Reason cGMP deviations: Temperature abuse
Reason cGMP deviations: Temperature abuse
Reason SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon…
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