Endo subsidiary Endo USA is expanding its previously announced voluntary recall of Clonazepam orally disintegrating tablets due to potential product strength mislabeling at the carton level.
The drugmaker's ongoing investigation has identified the possibility that multiple 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 product lots were distributed through wholesale distributors to retail pharmacies nationwide.
The initial recall, which involved just one product lot, was issued back in July when an incorrect strength appeared on the cartons, showing the product strength as 0.125 mg instead of 0.25 mg.
To date, there are no reports of adverse events linked to the recall but the risk is significant. Children and adults who inadvertently consume a higher dose of clonazepam could be at increased risk for 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.