Endo recalls panic disorder drug lot over labeling issue

Endo USA, a division of Endo Pharmaceuticals, has announced a voluntary recall of one lot of clonazepam tablets due to a labeling error. According to a press release dated July 16, the affected tablets, which are meant to be 0.25 milligrams, were incorrectly labeled as 0.125 milligrams on the cartons. However, the blister packs inside the cartons accurately depict the correct strength of the medication.

The company identified the labeling mistake as the fault of a third-party packager. Clonazepam is commonly prescribed for the acute treatment of conditions such as panic disorder, epilepsy, and nonconvulsive status epilepticus. It is also used in off-label applications to treat restless leg syndrome, acute mania, insomnia, and tardive dyskinesia.

The specific lot under recall was distributed in cartons containing 60 tablets each, bearing the National Drug Code (NDC) number 49884-307-02. These medications were distributed nationwide through wholesale channels to retail pharmacies. Endo USA has requested that pharmacies return any remaining inventory from this lot.

Endo has cautioned that the labeling error poses a significant risk of severe and potentially life-threatening respiratory depression, particularly for patients with underlying pulmonary conditions, those who are prescribed doses close to the maximum recommended levels, and patients who are also taking other medications that could further impact respiratory function.

As of now, the company has not received any reports of adverse events related to this recall. This incident follows another voluntary recall just four months ago involving a different Endo division, Par Pharmaceutical. In that case, a lot of treprostinil injection used for treating pulmonary arterial hypertension (PAH) was pulled from the U.S. market due to potential contamination with silicone particles. Treprostinil is a generic form of United Therapeutics’ Remodulin, a medication that has been available for over two decades.

Furthermore, in February, Endo Pharmaceuticals' parent company agreed to a bankruptcy settlement amounting to nearly $464.9 million. This settlement was in connection with a Department of Justice investigation into the company's prior marketing practices for the opioid painkiller Opana ER.