SAN FRANCISCO — Clonazepam, an anti-anxiety, seizure and muscle spasm medication was recalled by the manufacturer after labels were printed with the incorrect strength.
Endo, Inc. issued an expanded recall Monday warning about 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 original recall of Clonazepam Orally Disintegrating tablets was issued in July.
The company is worried mislabeling could lead to unintentionally taking higher doses, increasing the risk of serious side effects, including sedation, confusion, dizziness, loss of muscle coordination and muscle weakness.
Patients with concomitant pulmonary disease who take too much Clonazepam have a "reasonable probability" of shallow breathing, which can be fatal, according to the recall.
The tablets are used to treat Lennoz-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures and can help treat panic disorders, according to the company.
The recall says the misprint is on the outside carton of the medication, but the print on the tablets is accurate to the strength of the drug.
The mislabeled packaging was distributed nationwide. The impacted products are in cartons containing 60 tablets packed into 10 blister strips each containing 6 tablets. Find the impacted lot numbers here.
Endo, Inc. has advised consumers to stop using the affected tablets. There have been no reports of adverse effects due to the misprint.
