A nationwide recall has been issued for clonazepam, a widely used drug for reducing anxiety, due to a "potentially life-threatening" error.
The FDA stated that the medication's packaging was incorrectly labeled with the wrong strength.
The FDA has announced a recall of the anxiety-reducing drug Clonazepam due to a potentially "life-threatening" label mix-up.
The federal agency announced that Endo Inc. has voluntarily recalled 16 lots of Clonazepam Orally Disintegrating Tablets.
The pharmaceutical company announced an immediate recall of 16 lots of the anxiety drug due to incorrect labeling with the wrong strength and NDC by a third-party packager.
The FDA issued a warning that both children and adults taking Clonazepam could experience "dangerous" side effects.
The FDA stated that the mislabeling of the drug could lead to "significant sedation, confusion, dizziness, diminished reflexes, ataxia, and hypotonia."
The FDA stated that there is a high chance of severe, potentially fatal respiratory depression in patients with pre-existing lung disease, those who have been prescribed doses close to the maximum recommended amount, and those who are also taking other medications that may exacerbate respiratory depression.
As of Nov. 21, no adverse effects have been reported from the product recall by Endo Inc.
The FDA has released a table detailing the lots being added to the voluntary recall, including product descriptions and NDC numbers.
People who possess unused Clonazepam Orally Disintegrating tablets with the specified lot numbers should stop using the medication.
If a patient accidentally took the wrong dose, they should consult a doctor, the FDA advised.
Inmar Inc. can be contacted by consumers with questions about the recall through phone at 855-589-1869 or email at [email protected].
The Cleveland Clinic states that clonazepam tablets can treat both seizures and panic disorder.
"The Cleveland Clinic stated that it functions by reducing anxiety in your nervous system and is classified under the category of benzodiazepines."
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