Problems with medications that result in product recalls can result from any number of issues. In the case of a recent recall by Eli Lilly of some of its glucagon injection kits, there seem to have been longstanding issues at the site where the kits originated.
Last month, one lot of the kits (some 66,000 in the U.S. and Canada) was recalled after it was discovered that the kits’ liquid glucagon had been replaced with a powdered version. That powdered version is not as potent and therefore may not be effective when someone is suffering from extremely low blood sugar.
If a severe blood sugar issue isn’t corrected in time, a person can suffer seizures and neurological damage. It can even be fatal. According to the recall notice, at least one person suffered seizures after an injection from a kit in the recalled lot.
Recall follows FDA inspection that uncovered compliance and safety issues
The recall came a month after Form 483 was issued on the Indianapolis plant that produced the kits. This is a U.S. Food and Drug Administration (FDA) form issued by the agency to pharmaceutical companies notifying them that they’re not in compliance with its standards.
The FDA’s inspection of the plant earlier this year that led to the issuance of Form 483 found a number of quality and safety issues, including lax monitoring in aseptic (contamination-free) processing areas as well as employee fatigue that could lead to mistakes when preparing the kits. One employee reportedly had worked for 14 hours on one fulfillment line.
The company stated in part in its response to the FDA’s findings that “we have implemented or are implementing actions to resolve any concerns regarding this inspection on aggressive timelines.”
If you or a loved one has been harmed by a faulty drug and/or medical device, it’s crucial that you report the problem so that the manufacturers and appropriate authorities are aware of the issue and the full scope of the impact. It’s also wise to find out what your legal options are for seeking compensation to cover any expenses and damages.