Eli Lilly's recently recalled glucagon kits were produced at troubled Indianapolis site — report
Days after it was revealed that Eli Lilly’s diabetes injection kit had been recalled after a report of a mixup of glucagon substance, Reuters has reported the kits were manufactured in the Indianapolis plant called out in a Form 483.
On Sept. 24, the kit was recalled after liquid glucagon replaced the powdered version in the kit, which 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 death. One lot, D239382D with an expiration date of April 2022, has been recalled, and the company issued a recall the following day.
The recall notice said that a patient experienced seizures after they were injected with the drug, which was a sign that the drug wasn’t potent enough to be effective.
An Aug. 12 Form 483 called out Eli Lilly’s Indianapolis sterile injectables plant for several lapses in quality, and last week, the company issued a 95-page response. A Lilly spokesperson confirmed to news outlets this week that the kit was produced in the scrutinized Indiana plant.
Seven key observations came out of the FDA’s inspection, which took place between February and March of this year. A lackluster environmental monitoring control in aseptic processing areas, as well as a failure to address employee fatigue were among them, with an employee working for 14 hours on a filling line, which could lead to manual error on the filling line.
There were 66,000 glucagon kits affected in the recall, 19,000 of which were sent out within the US, and the rest in Canada.
The site makes bamlanivimab and etesevimab for COVID-19 and ramucirumab for NSC Lung Cancer in addition to glucagon.
The Form 483 was first reported by Reuters in May. Separately from the issues at the Indianapolis plant, Lilly employees in Branchburg, NJ accused quality control executives of altering FDA documents to downplay the seriousness of charges. That plant saw a human resources officer forced out of her job after raising concerns surrounding staff shortages and record keeping.
“We take the observations very seriously,” the company stated at the start of its response. “As detailed in our response, we have implemented or are implementing actions to resolve any concerns regarding this inspection on aggressive timelines. We thank the investigators for the discussions we had during the course of the inspection as the feedback contributes to enhancing our operational excellence.”