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. The blister strips inside the packaging show the correct strength of 0.
25 mg, according to the notice. Adults and children who are “inadvertently prescribed a two-fold overdose” could suffer health problems such as confusion, “significant sedation,” dizziness, and ataxia, or muscle weakness. The company warned that the mislabeling could increase the possibility of “significant” and “possibly life-threatening” respiratory issues for individuals with concomitant pulmonary disease as well as people who are taking other medication that could cause additional respiratory depression and for people who are taking near the maximum dose of clonazepam.
The firm said it has not received any reports of any adverse health events linked to the now-recalled product. Consumers who have any unused, prescribed 60-tablet cartons of Clonazepam Orally Disintegrating tablets, USP 0.25mg, that may also appear as Clonazepam Orally Disintegrati.