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Recall Observatory FDA recall evidence

Drug 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

D-0009-2022

September 24, 2021

Class I

Product summary

Firm
Eli Lilly & Company
Event
Event 88764
Status
Terminated
Classification
Class I
Quantity
19,174 syringes
Official record key
drug-enforcement:D-0009-2022

Official wording

Reason: SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.

Code information: Lot #: D239382D, Exp. Date April 2022

Distribution pattern: Nationwide with the USA and Puerto Rico; Canada, Argentina, Costa Rica, Mexico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    SUBPOTENT