United States: A popular drug, Clonazepam, is recalled by the FDA ( the US agency) after a possible life-threatening label error has been confirmed.
Although Endo Inc. has voluntarily recalled sixteen lots of Clonazepam Orally Disintegrating Tablets, the FDA confirmed the order to recall the popular anxiety drug.
The step to recall was taken into consideration after it was found that the tablets were mislabeled with incorrect strength and National Drug Code (NDC) information.
As per the official reports, the labeling mistake was attributed to a third-party packager.
Warning by the FDA
According to the FDA, the results of side effects on children and adults who were prescribed Clonazepam could be “life-threatening.”
The FDA statement also mentioned that the mislabeling of the drug could lead to “significant sedation, confusion, dizziness, diminished reflexes, ataxia, and hypotonia,” Fox News reported.
Moreover, “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,” the FDA added.
Endo Inc. stated that, as of November 21, there have been no reports of adverse effects related to the product recall.
The FDA has provided a table listing the affected lots, including the product descriptions and NDC numbers.
Patients with unused cartons of Clonazepam Orally Disintegrating Tablets from the recalled lots are advised to stop using the product.
If a patient accidentally took the wrong dose, they are urged to consult their physician, according to the FDA.
As per the Cleveland Clinic, Clonazepam tablets cure seizures and could also be used to cure panic disorder.
Moreover, the Clinic mentioned, “It works by helping your nervous system calm down,” Fox News reported.
“It belongs to a group of medications called benzodiazepines,” it added.