Drug Safety Alerts

Glucagon Voluntary Recall

9/25/2021

On September 25, 2021, Eli Lilly and Company (“Lilly”) issued a consumer-level recall of Glucagon® Emergency Kit for Low Blood Sugar (Glucagon for Injection, 1 mg per vial). This recall was issued because of a product complaint reporting that a vial of Glucagon was in liquid form instead of the powder form. According to Lilly, its 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.

This could be a health hazard or safety risk to patients who may be using product affected by this recall.

This recall affects lot number D239382D exp. 04/2022. No other lots are affected by this recall.

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 a lack of drug effect and subsequent seizures.

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.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program.

Lilly recommends that patients contact their physician if they have experienced any problems that may be related to taking or using this product.

For further information on this issue, please see the full Voluntary Recall notice at https://investor.lilly.com/node/45641/pdf

CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are using Glucagon® Emergency Kit for Low Blood Sugar to contact their prescriber.

For more information about Glucagon® Emergency Kit for Low Blood Sugar, please call Lilly Answers Center toll-free at 1 800-LILLYRX (1-800-545-5979), Monday through Friday, 9:00 AM to 7:00 PM (ET) or visit https://investor.lilly.com/node/45641/pdf. You may also call the United States Food and Drug Administration (FDA) toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit www.fda.gov