Eli Lilly investigators said there might have been an error in the manufacturing process of lot D239382D but did not elaborate further.
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Eli Lilly‘s manufacturing woes just seem to keep on compounding. On September 24, Eli Lilly voluntarily recalled an entire batch of Glucagon Emergency Kits in the U.S. and Canada following a report that a patient had gone into seizures after being injected with the drug.
On Monday, further details emerged, as a Reuters report stated that the batch in question was manufactured at an Indiana facility that had previously been cited by U.S. health regulators for quality-control violations, including several pertaining to this product.
The Indianapolis-based company specified lot D239382D of Glucagon Emergency Kit for Low Blood Sugar, consisting of 1mg per vial of Glucagon for injection and a 1 mL syringe diluent for Glucagon. It does not expire until April 2022. The batch had already reached consumer distribution, and there had been reports that the vial, which was supposed to be in powder form, was in liquid form. The liquid form of the product is not potent enough to treat severe low blood sugar.
Eli Lilly investigators said there might have been an error in the manufacturing process but did not elaborate further. The company issued the recall on September 24 in the U.S. and then in Canada the next day.
Glucagon Emergency Kit is used as an anti-hypoglycemic agent and gastrointestinal motility inhibitor for the treatment of severe hypoglycemia in pediatric and adult patients diagnosed with diabetes mellitus. The recall was prompted by a report that a patient had experienced lack of drug effect and subsequent seizures even after being given the medication.
The company called on distributors and wholesalers to halt distribution and quarantine stocks instantly. Pharmacists were advised to reach out to patients to whom the product was released, while patients were told to contact their pharmacists for details on return and replacement immediately.
“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,” said the company in a statement.
This is not the first time that Eli Lilly has been in the news for manufacturing problems. In May this year, employees anonymously alleged that a top executive at its New Jersey manufacturing facility had knowingly altered government-required documents to hide quality control problems at the factory where it is making its COVID-19 drugs. This was reportedly done amidst an investigation into the New Jersey site, which started in October 2020, to sway the government’s decision in their favor.
Speaking to reporters, a company spokesperson revealed that the recalls affected around 66,000 Glucagon Emergency Kits, some 19,0000 of which were distributed in the U.S. and the rest in Canada. The lot was manufactured in May 2020 at the Indianapolis facility.
The U.S. Food and Drug Administration has yet to comment officially on the matter, though spokesperson Jeremy Kahn told reporters that it is essential to note that Eli Lilly’s recall was voluntary. Kahn also said that the agency will continue to monitor the market and the situation.
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