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.
Glucagon Emergency Kit for Low Blood Sugar
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe. Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285; Glucagon, NDC: 0002-8031-01
Affected NDC
0002-8031-01
Compare with the code on your package — it is the most precise check available.
Drug: Glucagon
- Recalling firm
- Eli Lilly & Company
- Origin
- IN, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Sep 25, 2021 · FDA notice with lot numbers
- FDA recall number
- D-0009-2022 · 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
GlucaGen HypoKit
Defective delivery system: detached needles on the syringe in the kit.
Other recalls by Eli Lilly & Company
All 2021 recalls
Class II · Moderate risk
Sterile Diluent
CGMP Deviations
Class II · Moderate risk
Trulicity (dulaglutide)
Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.
Class II · Moderate risk
Zyprexa Intramuscular
cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
Class III · Low risk
ERBITUX CETUXIMAB Injection
Labeling: Missing label; potential for missing primary container label on the vial.
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