Endo recalls 1 lot of panic disorder drug due to labeling issue
17 Jul 2024
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Source: FiercePharma
Endo Pharmaceuticals' unit Endo USA has issued a voluntary recall of one lot of the anti-anxiety drug clonazepam.
Endo USA, a unit of Endo Pharmaceuticals, issued a voluntary recall of one lot of clonazepam tablets due to a labeling issue that resulted in an incorrect strength being printed on the cartons.
The recall affects 0.25 milligram tablets with labeling that wrongly indicates they were 0.125 milligrams in strength, the company said in a July 16 press release. Despite the error, the blister pack featured the correct strength description.
The company said the error was due to a third-party packager.
Clonazepam is typically used for acute treatment of panic disorder, epilepsy, and nonconvulsive status epilepticus. It is also used for off-label treatment of restless leg syndrome, acute mania, insomnia, and tardive dyskinesia.
The recalled lot was packaged in cartons of 60 tablets with a National Drug Code (NDC) number 49884-307-02. The drugs were distributed nationwide through wholesale distributors to retail pharmacies, which are being asked to return any existing inventory they have.
Endo warned that there is a “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 hasn’t received any reports of adverse events associated with the recall, the company said.
The latest voluntary recall falls just four months after another Endo unit, Par Pharmaceutical, recalled one lot of its pulmonary arterial hypertension (PAH) drug treprostinil injection from the U.S. market over concerns that silicone particles could be in vials of the drug.
Treprostinil is a generic to United Therapeutics’ Remodulin, which has been marketed for over 20 years.
In February, the parent company Endo, agreed to pay a bankruptcy settlement worth up to $464.9 million to the federal government after a Department of Justice investigation into its previous marketing of opioid painkiller Opana ER.
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