FDA Announces Recall of Panic Disorder Drug Over Mislabeling

Endo USA Inc. announced that it is recalling a batch of clonazepam disintegrating tablets because of mislabeled strength information. The company warns consumers not to take the drug, according to a notice published by the U.S. Food and Drug Administration (FDA) this past week. Clonazepam, which is sometimes marketed as Klonopin, is a benzodiazepine that is approved by the FDA to treat anxiety, epilepsy, and panic disorders. Off-label, the drug can be prescribed for restless leg syndrome, insomnia, and acute mania. The single product lot of Clonazepam Orally Disintegrating tablets was recalled because of a “mislabeling where an incorrect strength appears on the cartons of some packs to show the product strength as 0.125 mg and not 0.25 mg due to an error at a third-party packager,” Endo USA said in the FDA notice....