A popular and widely-used anxiety drug Clonazepam—often known as Klonopin—is being voluntarily recalled due to “potential product carton strength mislabeling.” According to the FDA, this mistake carries a “reasonable probability for significant, possibly life-threatening, respiratory depression” for patients, especially those who are already taking max doses.
Endo, Inc. issued a voluntary recall for Clonazepam tablets on November 18, stating that its “ongoing investigation has identified the possibility that the Clonazepam product lots listed below contain a limited number of cartons printed with the incorrect strength and National Drug Code (NDC) code due to an error by a third-party packager. The blister strips and tablets inside the product pack reflect the correct strength for the lot.”
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Thankfully, there have not yet been any reported issues from patients taking this medication—at least not before the recall was announced.
Clonazepam, which is part of the drug class benzodiazepines, is often used to treat seizures, anxiety, and panic disorders, calming the nervous system. However, too high of doses or interactions with other medications could cause respiratory depression.
“Our first priority at Endo is the quality and safety of our products and well-being of patients,” Linda Huss said in a statement to USA TODAY. “Our own quality investigation identified a potential label inaccuracy at a third-party vendor, leading to this expanded recall of a limited number of product lots that were packaged earlier this year.”
“We communicated transparently to our customers and the FDA, which has concluded its review of the issue and our response, and have resolved this issue,” Huss added.
