A popular medication used to treat seizures and panic disorder is being urgently recalled after authorities learned that the tablets were actually twice as strong as the label claimed.
Endo Inc. and the FDA issued a recall for Clonazepam Orally Disintegrating Tablets after an error from a third-party packaging company caused the strengths of the medication to be mislabeled, leading some medications to only be listed at half their actual strength.
This could pose a serious health risk to some, and could even be life-threatening for others, according to the FDA.
"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," Endo Inc. said in a statement.
The company added that children and adults who consume high levels of the medication could be at higher risk for experiencing "significant sedation, confusion, dizziness, diminished reflexes, ataxia and hypotonia."
The blister strips and tablets inside the packaging are said to state the correct dosage, but the outside packaging is incorrect. Endo Inc. and the FDA included a table in their statements for the product descriptions and NDC numbers involved in the recall.
No claims of adverse reactions have been reported as of Thursday.
Consumers are asked to discontinue use of the product, and to call a physician if it is believed they took the incorrect dosage.
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