Recall report: Eli Lilly pulls diabetes emergency kit after manufacturing mishap
A diabetes injection kit from Eli Lilly has been recalled after reports that the vial of glucagon was in the form of a liquid instead of powder, the FDA says.
The mixup has been attributed to the manufacturing process, the company said. Using liquid glucagon instead of the powder could fail to treat severe low blood sugar, due to a loss of potency. If not reversed, extreme low blood sugar can lead to neurological damage, seizures, and even death if left untreated.
One lot of the glucagon emergency kit for low blood sugar, D239382D with an expiration date of April 2022, has been recalled. The lot number can be found on the label of the kit, as well as the vial. The kit contains 1 mg vials of glucagon for injection.
In a statement, Lilly said:
Lilly is deeply committed to manufacturing high-quality medicines for patients who need them, and the safety and quality of our products is our highest priority. We take our obligations seriously and have rigorous quality systems in place to ensure compliance with stringent regulatory requirements. 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.
Any person who experiences side effects should report them to the FDA’s MedWatch program, either online or by calling 1-800-FDA-0178. Customers with an emergency kit from the recalled lot should call the Lilly Answers Center at 1-800-LILLYRX. Wholesalers and pharmacists should notify Sedgwick at 877-907-7032, by fax at 877-884-9410, or by email at firstname.lastname@example.org to start the return process.
Glucagon is also used to stop movement in the intestines in people receiving radiology exams.
This recall marks the seventh drug in September alone that has been recalled, according to the FDA.