Eli Lilly’s Recalled Glucagon Emergency Kits Were Manufactured in a Plant Previously Cited By the FDA
According to a news report on streetinsider.com, Eli Lilly and Company announced the recall of one batch of its Glucagon Emergency Kits. The recalled Glucagon Emergency Kits were manufactured at an Indiana factory that has a history of citations from U.S. health regulators. In 2021, the Indian plant was cited for several violations concerning product quality control.
On September 24, 2021, Eli Lilly issued a voluntary recall for one of the Glucagon Emergency Kits containing the key ingredient Glucagon. Glucagon is a medication that is used to treat “dangerously low blood sugar in diabetes patients.” Eli Lilly then issued another recall in Canada the next day.
Eli Lilly’s recall notice declared that the company had received an incident report of a patient who experienced seizures after they were injected with the drug. It is believed that this shows the medication wasn’t strong enough to work. Eli Lilly also stated that the product’s failure could be related to its production process.
Eli Lilly is facing federal criminal investigations into the alleged manufacturing inconsistencies at another of the company’s U.S. factories based in New Jersey.
According to an official statement from Eli Lilly, the company stated it is deeply committed to its manufacturing process of high-quality medicines.
Approximately 66,000 Eli Lilly Glucagon Emergency Kits were recalled, Eli Lilly spokeswoman Kathryn Beiser reported. Ms. Beiser also reported that Eli Lilly shipped approximately 19,000 of the Glucagon Emergency Kits were shipped throughout the United States, and the rest were shipped to Canada. She did not state if Eli Lilly had received any adverse health event reports related to the Glucagon Emergency Kits.
The recalled Eli Lilly Glucagon Emergency Kits were made for diabetes patients whose blood sugar is dropping, and the patient needs to raise its blood sugar quickly to avoid seizures or death. The Glucagon Emergency Kits consists of a syringe filled with liquid and a vial of freeze-dried Glucagon powder.
According to the U.S. Food and Drug Administration, the agency’s inspection records cited the plant with numerous quality control violations. The news report states that the plant’s staff failed to effectively monitor environmental conditions where the medications are made and preventing contamination. According to the FDA’s inspection records, they witnessed lapses in the production of the Glucagon kits. The inspectors concluded that Eli Lilly took steps to correct the lapses.
FDA spokesman Jeremy Kahn said that the recall was a voluntary action conducted by the company and the FDA is closely evaluating the recall. The FDA did not state whether or not there were reports of adverse medical events, if the agency re-inspected Eli Lilly’s Indianapolis plant, or if the agency would take additional actions.
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