, /PRNewswire/ -- Endo, Inc (OTCQX: ) ("Endo"), announced today that one of its operating subsidiaries, Endo , Inc., is voluntarily recalling one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets, which may also appear as Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.
125 tablets 60-count pack to the consumer level. The product lot is being recalled due to 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. The blister strips inside the product pack reflect the correct strength of 0.25 mg.
: Children and adults who are inadvertently prescribed a two-fold overdose of clonazepam would be at risk for the adverse effects of significant sedation, dizziness, ataxia, and confusion. 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. To date, Endo has not received any reports of adverse events associated with this product lot recall.
Clonazepam Orally Disintegrating Tablets are indicated alone for as an adjunct in the treatment of the Lennoz-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. Additionally, the product is indicated for the treatment of pan.