FDA MedWatch - One Lot of GLUCAGON Emergency Kit by Eli Lilly:

U.S. Food and Drug Administration sent this bulletin at 09/27/2021 01:58 PM EDT

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: One Lot of GLUCAGON Emergency Kit by Eli Lilly: Recall - Due to Loss of Potency

AUDIENCE: Patient, Consumer, Health Professional, Risk Manager, Pharmacy, Wholesaler

ISSUE: Eli Lilly and Company is recalling lot D239382D, Expiration April 2022, of Glucagon Emergency Kit for Low Blood Sugar (Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe) because of a product complaint reporting that the vial of Glucagon was in liquid form instead of the powder form. The firm’s investigation indicates that the liquid in this Glucagon vial could be related to the manufacturing process. The use of the liquid form of this product may fail to treat severe low blood sugar due to loss of potency.

Risk Statement: Severe hypoglycemia in patients with diabetes, if not reversed, can potentially cause adverse health consequences ranging from transient, minor complaints to neurological damage, seizures, and even death if not promptly treated. Associated with the one product complaint, it was reported to Lilly that the involved patient experienced lack of drug effect and also reported subsequent seizures.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: Glucagon Emergency Kit is used as an anti-hypoglycemic agent and a gastrointestinal motility inhibitor indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus.

RECOMMENDATIONS:

Instructions for Wholesalers and Pharmacists:

Wholesalers and Distributors with an existing inventory of Glucagon Emergency Kit lot D239382D should cease distribution and quarantine the product immediately.

If you have distributed the recalled product, please notify any accounts or additional locations which may have received product from the recalled lot from you.
Please conduct a sub-recall to those accounts and communicate this recall information immediately. Please request they immediately cease distribution of the product and promptly contact Sedgwick.

Instructions for Consumers:

Consumers in possession of Glucagon Emergency Kit lot D239382D should contact The Lilly Answers Center for return and replacement instructions for the product.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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FDA MedWatch - One Lot of GLUCAGON Emergency Kit by Eli Lilly:

TOPIC: One Lot of GLUCAGON Emergency Kit by Eli Lilly: Recall - Due to Loss of Potency

TOPIC: One Lot of GLUCAGON Emergency Kit by Eli Lilly: Recall - Due to Loss of Potency