United States
Company name: Eli Lilly and Company
Brand name: Lilly
Product recalled: Glucagon Emergency Kit
Reason of the recall: Loss of potency
FDA Recall date: September 26, 2021
Recall details: Eli Lilly and Company (NYSE: LLY) is voluntarily 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), to the consumer/user level. Lilly is recalling lot D239382D to the patient level 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.
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. The product is packaged in a kit containing 1mg of freeze-dried (lyophilized) product in a 3 mL vial and a pre-filled diluent syringe. The affected Glucagon Emergency Kit lot is D239382D and the expiration date is April 2022 (label expiry date: 04 2022). The lot number can be found on the label of the kit as well as the vial (refer to the photos provided below – Appendix A). The lot was distributed nationwide to wholesalers and retailers.
Wholesalers and Distributors with an existing inventory of Glucagon Emergency Kit lot D239382D should cease distribution and quarantine the product immediately.
Instructions for Wholesalers and Pharmacists: 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.
Instructions for Consumers: Consumers in possession of Glucagon Emergency Kit lot D239382D should contact The Lilly Answers Center at 1-800-545-5979 for return and replacement instructions for the product (hours of operation are Monday- Friday, 9AM – 7PM EST) and should contact their health care provider for guidance. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. APPENDIX A The Lot Number is found on the kit and vial labels as can be seen in the example label below.
Check the full recall details on
www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/eli-lilly-and-company-issues-voluntary-nationwide-recall-one-lot-glucagonr-emergency-kit-due-loss
Source: FDA
