Endo Expands Voluntary Recall of Clonazepam Orally Disintegrating Tablets

Endo has expanded its previously announced voluntary recall of Clonazepam Orally Disintegrating Tablets due to “potential product carton strength mislabeling.” FDA has the release.

Endo’s investigation has identified the possibility that certain Clonazepam product lots “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.” The FDA release contains the lot numbers affected.

People 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.” There have been no adverse effects associated with this recall to date.