After a labeling mix-up prompted a recall of a popular panic disorder drug this summer, Endo’s U.S. subsidiary is widening the scope of its product pull.
Endo USA is expanding its previous recall of orally disintegrating clonazepam tablets to include more than a dozen additional product lots, the company said in a notice posted on the FDA’s website Tuesday.
The recall is being issued thanks to an “error by a third-party packager” that led to certain cartons displaying the wrong strength and National Drug Code for the product they contain, Endo said.
Overall, 16 suspect lots have been implicated in the latest generic clonazepam pull. The batches in question contain 0.125-mg, 0.25-mg, 1-mg and 2-mg doses of the drug and were shipped out to wholesalers and retail pharmacies around the U.S.
The blister strips and tablets inside the carton packaging should reflect the correct strengths for their respective lots, Endo explained.
Endo’s generic clonazepam—which references the well-established benzodiazepine Klonopin—is approved to treat panic disorder as well as Lennox-Gastaut syndrome and akinetic and myoclonic seizures.
People who take more clonazepam than intended could suffer serious side effects such as significant sedation, confusion and dizziness, according to the recall notice. Plus, patients with pulmonary disease, patients near maximum clonazepam dosing and those on certain other medications are at risk of potentially life-threatening respiratory depression should they receive the wrong doses, Endo warned.
To date, the company says it has not received any side effect or safety signal reports tied to the recall.
The latest update in Endo’s clonazepam packaging odyssey comes after the company in July initiated a voluntary recall on a single lot of 0.25-mg tablets with cartons mislabeled to read 0.125 mg.
Prior to that, Endo’s Par Pharmaceutical unit said in March that it was recovering one batch of the injectable pulmonary arterial hypertension drug treprostinil from the U.S. market. In that instance, the recall was spurred on by concerns of silicone particles potentially turning up in vials of the drug.
The prostacyclin vasodilator treprostinil is a generic to United Therapeutics’ Remodulin, which has been on the market for more than two decades.