FDA Recall D-0009-2022
Eli Lilly & Company · Indianapolis, IN
Class I — life-threatening Terminated 1078 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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
Reason for recall
SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
Recall record
- Recall number
D-0009-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide with the USA and Puerto Rico; Canada, Argentina, Costa Rica, Mexico
- Recall initiated
- 2021-09-24
- Classified by FDA Center
- 2021-10-14
- FDA published
- 2021-10-20
- Terminated
- 2024-09-06
- Recalling firm
- Eli Lilly & Company
- Firm location
- Indianapolis, IN