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.
Breaking News
Jul 18, 2024
Mrudula Kulkarni

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.