Recalls / Class I
Class ID-0009-2022
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
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 lot / code info
- Lot #: D239382D, Exp. Date April 2022
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.
Recalling firm
- Firm
- Eli Lilly & Company
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 839 S Delaware St, N/A, Indianapolis, Indiana 46225-1782
Distribution
- Quantity
- 19,174 syringes
- Distribution pattern
- Nationwide with the USA and Puerto Rico; Canada, Argentina, Costa Rica, Mexico
Timeline
- Recall initiated
- 2021-09-24
- FDA classified
- 2021-10-14
- Posted by FDA
- 2021-10-20
- Terminated
- 2024-09-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0009-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.