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.
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.
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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