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Endo's Panic Disorder Drug Recall Sparks Health Alert Over Labeling Mistake

Endo USA recalls clonazepam tablets due to labeling error; no adverse events reported so far.

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  • Jul 18, 2024

  • Mrudula Kulkarni

Endo's Panic Disorder Drug Recall Sparks Health Alert Over Labeling Mistake

Endo USA, a division of Endo Pharmaceuticals, has initiated a voluntary recall of a specific batch of clonazepam tablets. The recall was prompted by a labeling discrepancy where the cartons incorrectly stated the strength as 0.125 milligrams instead of the actual 0.25 milligrams. Despite this error, the blister packs correctly indicated the accurate strength, as reported in a press release on July 16. The labeling mistake was attributed by the company to a third-party packaging contractor.

Clonazepam is commonly prescribed for the immediate relief of panic attacks, epilepsy, and nonconvulsive status epilepticus. It is also utilized off-label for conditions such as restless leg syndrome, acute mania, insomnia, and tardive dyskinesia. The affected batch, packaged in cartons containing 60 tablets with the National Drug Code (NDC) number 49884-307-02, has been distributed across the country through wholesale distributors to retail pharmacies. Pharmacies are requested to return all inventory from this lot.

Endo alerted 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.”

According to Endo, there have been no reports of adverse events linked to the recall so far. This recent voluntary recall follows closely on the heels of another by Endo's subsidiary, Par Pharmaceutical. Four months ago, Par Pharmaceutical recalled a batch of its treprostinil injection, used to treat pulmonary arterial hypertension (PAH) in the United States. The recall was prompted by concerns that some vials of the drug may contain silicone particles.

Treprostinil is a generic version of United Therapeutics’ Remodulin, a well-established medication in use for more than two decades. In February, Endo's parent company reached a settlement with the federal government, agreeing to pay up to $464.9 million to resolve allegations related to the marketing of the opioid painkiller Opana ER following a Department of Justice investigation.

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