Drug manufacturer Endo announced on Friday that one of its operating subsidiaries, Endo USA, Inc., is expanding its previously announced voluntary recall of Clonazepam Orally Disintegrating Tablets, a popular anxiety drug, due to potential product carton strength mislabeling.
Their announcement stated that specifically, Endo’s ongoing investigation has identified the possibility that certain Clonazepam lot numbers 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.
According to its risk assessment portion Endo’s announcement, children and adults who inadvertently consume a higher dose of clonazepam could be at increased risk for the adverse events of significant sedation, confusion, dizziness, diminished reflexes, ataxia, and hypotonia. 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 says it has not received any reports of adverse events associated with this product recall.