A popular anxiety-reducing drug and anti-seizure medication has been recalled due to a potentially life-threatening label mix-up, according to the FDA.
Endo Inc. says certain lots of its Clonazepam Orally Disintegrating Tablets are packaged in cartons printed with the incorrect strength and National Drug Code.
The labeling error, made by a third-party packager, could lead to serious side effects like sedation and hypoventilation if a patient inadvertently consumes a higher dose of clonazepam than prescribed.
"There is reasonable probability for significant, possibly life-threatening, respiratory depression especially for patients with concomitant pulmonary disease, patients who have prescribed dosing near maximal dosing, and patients also taking other medications that could cause additional respiratory depression," Endo said in a statement.
The company originally recalled one product lot of the tablets in July after the issue was discovered.
The recall was expanded on November 18 to include 16 additional product lots. The recall notice did not mention how many product units were potentially affected by the issue.
To date, Endo has not received any reports of adverse events associated with the product recall.
Patients with affected tablets are advised to discontinue use and consult a physician.
Clonazepam is used in the treatment of certain seizures and Lennoz-Gastaut syndrome, a rare form of epilepsy. It is also used for the treatment of panic disorder.