Drug recall notice for Glucagon Emergency Kit

A physician holds a vial of pills while taking notes at a computer.

To assist you in the care of your patients, we would like to alert you to the recall of one lot of Glucagon® Emergency Kit for low blood sugar (Glucagon for injection, 1 mg per vial; diluent for Glucagon, 1 mL syringe) on Sept. 26, 2021.1 We recommend you review your medical records and contact all patients for whom you have prescribed this medication to warn them of the recall.

The drug manufacturer, Eli Lilly and Company, is voluntarily recalling this product due to a complaint that the vial of Glucagon was in liquid form instead of the powder form. The 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.

Other lot numbers of Glucagon Emergency Kit are unaffected and available.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Medications included in this recall

Product name NDC number Lot number Expiration date Glucagon for injection, 1 mg per vial; diluent for Glucagon, 1 mL syringe 00002803101 D239382D 04/2022

Information for providers:1

  • We have sent a letter to your Humana-covered patients who have had a claim for Glucagon and asked them to contact their physicians or healthcare providers if their medication is included in the recall and if they have experienced problems that may be related to using these drug products.
  • For return and replacement instructions for the product or further information, healthcare providers can contact The Lilly Answers Center at 800-LILLYRX (545-5979), Monday – Friday, 9 a.m. – 7 p.m., Eastern time.
  • Patients may report adverse reactions or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
    • Online: Complete and submit the report.
      • Select “Consumer/Patient (FDA Form 3500B).”
    • Regular mail or fax: Download the form.
      • Select “Form FDA 3500B – Voluntary Reporting for Consumers” and submit by mail to the address on the form or by fax to 800-FDA-0178 (332-0178).

Reference:

  1. “Eli Lilly and Company Issues Voluntary Nationwide Recall of One Lot of GLUCAGON® Emergency Kit Due to Loss of Potency,” U.S. Food and Drug Administration, last accessed Sept. 29, 2021, www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/eli-lilly-and-company-issues-voluntary-nationwide-recall-one-lot-glucagonr-emergency-kit-due-loss.