Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe. R
Summary
The FDA issued a Class I for Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per via by Eli Lilly & Company. Reason: SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administr.
Details
Source
Drug Recall
External ID
D-0009-2022
Action Date
2021-10-20
Status
Terminated
Category
drug
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
Lot/Code Info: Lot #: D239382D, Exp. Date April 2022
Quantity Affected: 19,174 syringes
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
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-24
Company
Indianapolis, IN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 22 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Eli Lilly & Company has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Eli Lilly & Company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Eli Lilly & Company have FDA actions?
Eli Lilly & Company has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0009-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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