Class I Recall for Hypoglycemia Emergency Kits

A Class I recall is in effect for a single lot of Eli Lilly & Company’s Glucagon Emergency Kit for Low Blood Sugar after a customer reported a vial containing glucagon in liquid rather than powder form. The recall is included in the October 20, 2021, US Food and Drug Administration (FDA) Enforcement Report.

Class I, the FDA’s most serious recall, warns that use of affected products could result in serious adverse health consequences or death. In a September 25, 2021, announcement, recalling firm Eli Lilly and Company explained that using the liquid form of the product may fail to treat severe low blood sugar due to loss of potency.

“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,” the announcement stated. “Associated with the one product complaint, it was reported to [Eli] Lilly that the involved patient experienced lack of drug effect and also reported subsequent seizures.” 

The recall affects Glucagon Emergency Kit for Low Blood Sugar (glucagon for injection, 1 mg per vial; diluent for glucagon, 1-mL syringe; NDC 0002-8031-01) from lot D239382D (Exp. 4/22). The kits were distributed within the United States, Puerto Rico, Canada, Argentina, Costa Rica, and Mexico. 

“The firm’s investigation indicates that the liquid in this glucagon vial could be related to the manufacturing process,” Eli Lilly and Company stated.

The company voluntarily initiated the recall September 24, 2021. The FDA categorized it Class I October 14, 2021.  

Available with a prescription, the Glucagon Emergency Kit is indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes mellitus. 

“Wholesalers and distributors with an existing inventory of Glucagon Emergency Kit lot D239382D should cease distribution and quarantine the product immediately,” Eli Lilly & Company advised.