FDA recall D-0009-2022

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2021-09-24

Report date

2021-10-20

Termination date

2024-09-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Indianapolis, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0009-2022