Marisa Taylor and Dan Levine

(Reuters) – A recently recalled batch of Glucagon Emergency Kits, Eli Lilly (NYSE:) and Co’s therapy for diabetic patients in crisis, was manufactured at an Indiana factory cited by U.S. health regulators this year for quality-control violations, including several involving that product, according to the company and a Reuters review of federal inspection records.

A voluntary recall was issued by the U.S. company, based in Indianapolis on September 24th. The key ingredient of this kit is Glucagon. It’s a medication that treats dangerously low blood glucose for diabetic patients. Canada was the next day, and the company also issued a voluntary recall.

Lilly’s recall notices said that the company had received a report of a patient who experienced seizures even after being injected with the drug, a sign that the treatment was not potent enough to work. The manufacturer of the drug could have caused product failure, but Lilly did not elaborate.

In response to Reuters’ inquiries, Lilly told the news organization that the affected kits were produced at a company facility in Indianapolis, and that the kit that prompted the recall had been distributed in Canada. Reuters reported that the U.S. Health regulators had cited the Indianapolis plant for not following quality control and sanitation standards.

Lilly also faces a federal criminal probe into alleged manufacturing problems in New Jersey. The details were first reported on Reuters this year. The recall of Glucagon kits made in Indianapolis is the first indication of potential patient harm due to recent manufacturing issues at the company’s plants.

“Lilly is deeply committed to manufacturing high-quality medicines for patients who need them—nothing is more important to us,” the company said in a statement. “We take our obligations seriously and have rigorous quality systems in place to ensure compliance with stringent regulatory requirements.”

Kathryn Beiser spoke on behalf of Lilly and said that recalls had affected roughly 66,000 Glucagon Emergency Kits. According to her, 19,000 were sent out to U.S. consumers and almost all of the remainder went to Canada. The kits were manufactured at the Indianapolis facility in May 2020, she said. Beiser refused to comment on whether Lilly had received any other adverse reactions to the Glucagon kit.

EMERGENCY KITS

This recalled Glucagon Crisis Kit is for patients with diabetes who have their blood sugar dropping and must quickly get it up to avoid seizures or death. This kit includes a vial containing freeze-dried Glucagon and a separate syringe containing liquid.

Glucagon powder is usually administered by a caregiver who inserts a liquid-filled syringe into the vial. Lilly announced that the liquid contained in the vial of the patient with the flu was liquid.

The company’s Indianapolis plant performs what is known in the industry as “fill and finish” – receiving raw drugs made at other facilities, putting them into vials and syringes, and shipping them to customers.

Reuters reviewed U.S. Food and Drug Administration records from March 2021. They cited many quality control violations at the plant. These included staff failure to monitor environment conditions in which drugs are manufactured and failure to set up appropriate protocols to avoid contamination.

The FDA inspectors said they observed lapses in the manufacturing of the Glucagon kits as well as in Lilly’s COVID-19 antibody therapy bamlanivimab and several other drugs, according to the inspection records, dated March 16. Although they recommended that Lilly take action to correct the errors, the FDA did not endorse their recommendation.

Beiser spoke for Lilly and stated that U.S. distribution from the lot of Glucagon Emergency Kits was halted by March 25, a little over a week after FDA inspection. Beiser said the distribution of the lot followed its regular process via wholesaler channels and was not related to the FDA report, adding that “any suggestion” it ended for other reasons is false.

Beiser noted that the distribution of emergency kits from this same batch was continuing in Canada. According to Beiser, the distribution of 44,000 kits throughout Canada started in February 2021. It continued into September. Beiser explained to Reuters that the kit involved in the patient complaint which triggered Canada’s late September recall was shipped from Canada.

Beiser did not comment on the reason why the Canada distribution of Glucagon Emergency Kits continued for six months, despite the fact that distribution in the United States had ceased. The question of whether or not the patient was able to recover from her injuries did not get answered by Beiser.

Health Canada, a regulatory agency similar to the U.S. FDA, declined to comment about Lilly’s voluntary recall of the Glucagon Emergency Kits, or why kits from the batch continued to be distributed in Canada for months after they had ceased to be distributed in the United States.

FDA refused to comment about distribution, and whether there had been any reports of adverse reactions.

“It is important to note that this recall was a voluntary action taken by the company,” FDA spokesman Jeremy Kahn said, without elaborating. “We have been closely evaluating this event and will continue to monitor the marketplace and manufacturing efforts to help ensure the availability of safe products for U.S. consumers.”

FEDERAL PROBE

This recall is being made as Lilly comes under criminal investigation by U.S. Department of Justice for alleged manufacturing irregularities, records-tampering and production errors at another factory in Branchburg (New Jersey) that makes bamlanivimab, and other drugs.

Lilly has been cleared by the Justice Department of all wrongdoing. The company also stated earlier in this year that they are cooperating with the investigation. Reuters asked Lilly about the progress of this investigation. The Justice Department didn’t respond to our request for comment.

Bamlanivimab has been shipped to Indianapolis, fill-and finish plant, to be used in the manufacture of the COVID-19 antibodies.

According to Reuters, a report redacted by the FDA inspectors that was obtained through a Freedom of Information Act request, the group arrived in Indianapolis around February and stayed there for over two weeks.

In their report, the inspectors listed Glucagon as among the drugs where Lilly “failed to establish an adequate system for monitoring environmental conditions,” and noted that Lilly failed to establish and follow appropriate written procedures “to prevent microbiological contamination of drug products purporting to be sterile.”

The inspectors found out that Lilly had not conducted quality control sampling on glass components, such as vials or pharmaceutical ingredients for drugs, including Cyramza and Glucagon.

In Lilly’s April 6 response to the FDA obtained by Reuters through an open records request, the company said it takes the inspectors’ findings “very seriously” and is implementing actions to resolve concerns “on aggressive timelines.”

The redacted response stated that Lilly had created an environmental monitoring system to evaluate microbiological control within manufacturing environments. It did not answer questions regarding the company’s efforts to correct violations found at its Indianapolis plant by FDA.