Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Gl...

FDA Recall #D-0009-2022 — Class I — September 24, 2021

Recall #D-0009-2022 Date: September 24, 2021 Classification: Class I Status: Terminated

Product Description

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.

Recalling Firm

Eli Lilly & Company — Indianapolis, IN

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

19,174 syringes

Distribution

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

Code Information

Lot #: D239382D, Exp. Date April 2022

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated