Eli Lilly issues voluntary recall of glucagon emergency kit for loss of potency
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Eli Lilly is voluntarily recalling one lot of glucagon emergency kits at the patient level after a product complaint reporting a vial of glucagon was in liquid instead of powder form, according to an FDA press release.
An investigation indicates that the liquid in the glucagon vial could be related to the manufacturing process, according to the release. The use of the liquid form of this product may fail to treat severe hypoglycemia due to loss of potency. Eli Lilly is recalling lot D239382D (glucagon for injection, 1 mg per vial; diluent for glucagon, 1 mL syringe), with the expiration date of April 2022.
Severe hypoglycemia in people with diabetes, if not reversed, can potentially cause adverse health consequences ranging from transient, minor complaints to neurologic damage, seizures and 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,” the release states.
Glucagon Emergency Kit is used as an anti-hypoglycemic agent and a gastrointestinal motility inhibitor indicated for the treatment of severe hypoglycemia in children and adults with diabetes.
The product is packaged in a kit containing 1 mg of lyophilized product in a 3 mL vial and a pre-filled diluent syringe. The lot number can be found on the label of the kit as well as the vial. The lot was distributed nationwide to wholesalers and retailers.
Eli Lilly is notifying its distributors and customers by written communication and is arranging for return and replacement of all recalled products. Wholesalers and distributors with an existing inventory of Glucagon Emergency Kit lot D239382D should cease distribution and quarantine the product immediately, according to the release.
Consumers in possession of Glucagon Emergency Kit lot D239382D should contact the Lilly Answers Center at 1-800-LILLYRX (1-800-545-5979) for return and replacement instructions for the product and should contact their health care provider for guidance. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this product.
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