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Lilly Recalls One Lot Of GLUCAGON Emergency Kit

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Eli Lilly and Co. is recalling one lot of GLUCAGON Emergency Kit for low blood sugar to the consumer/user level citing loss of potency, the U.S. Food and Drug Administration announced.

The recall involves lot D239382D with expiration date of April 2022 of Glucagon Emergency Kit containing 1mg of freeze-dried (lyophilized) product in a 3 mL vial and a pre-filled diluent syringe. The lot was distributed to wholesalers and retailers across the United States.

The recall was initiated following a product complaint reporting that the vial of Glucagon was in liquid form instead of the powder form.

Lilly's investigation indicates that the liquid in the Glucagon vial could be related to the manufacturing process. The use of the liquid form of the product may fail to treat severe low blood sugar due to loss of potency.

According to the agency, severe hypoglycemia in patients with diabetes, if not reversed, can potentially cause adverse health consequences. This ranges from transient, minor complaints to neurological damage, seizures, and even death if not promptly treated.

In the one product complaint reported to Lilly, 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.

Lilly urged wholesalers and distributors with an existing inventory of Glucagon Emergency Kit lot D239382D to cease distribution and quarantine the product immediately.

Consumers in possession of the recall product should contact Lilly Answers Center for return and replacement instructions.

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