The US Food & Drug Administration said batches of anxiety-reducing drug Clonazepam have been recalled after a potentially “life-threatening” label mix-up.
According to a release from the agency, pharmaceutical company Endo has announced a voluntary recall of 16 lots of Clonazepam Orally Disintegrating Tablets, saying the immediate recall followed the discovery that 16 lots of the drug were mislabelled with the incorrect strength and National Drug Code (NDC) on them.
The company blamed the error on a third-party packager, reports Fox News.
The FDA has warned that the mistake means children and adults prescribed Clonazepam could face “life-threatening” side effects, like “significant sedation, confusion, dizziness, diminished reflexes, ataxia, and hypotonia”.
“There is 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,” it cautioned.
Endo noted that, as of 21 November, there have not been any reports of adverse effects from the product recall.
Clonazepam tablets treat seizures and can also be used to treat panic disorder as well as neuralgia, said the Cleveland Clinic. “The drug works by helping your nervous system calm down and belongs to a group of medications called benzodiazepines.”
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