Clonazepam, an anti-anxiety medication, has been recalled due to a potentially “life-threatening” label mix-up, according to the Food and Drug Administration (FDA).
Endo Inc. has voluntarily recalled 16 lots of Clonazepam Orally Disintegrating Tablets, according to a federal agency press statement.
The pharmaceutical company announced the urgent recall after discovering that 16 lots of anxiety medicine were mislabeled with the improper strength and National Medicine Code (NDC). The company stated that the labeling error was made by a third-party packager.
As a result, children and adults taking Clonazepam may experience “life-threatening” side effects, the FDA cautioned.
The mislabeling of the medicine could cause “significant sedation, confusion, dizziness, diminished reflexes, ataxia, and hypotonia,” according to the FDA.
Endo Inc. stated that as of November 21, there had been no reports of adverse consequences from the product recall.
Endo stated on their website: “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.”
Individuals holding unused prescribed pill cartons of Clonazepam Orally Disintegrating tablets carrying the lot numbers have been advised to stop using the medicine.
If a patient mistakenly takes an incorrect dose instead of the recommended dose, the FDA advises them to visit a physician.
If a patient mistakenly takes an incorrect dose instead of the recommended dose, the FDA advises them to visit a physician.
About Clonazepam
Respiratory depression occurs when breathing becomes slow, shallow, or ineffective, and it can be fatal.
Clonazepam is used to treat seizure disorders such as epilepsy, panic disorder (a type of anxiety in which a person experiences recurrent panic attacks), and other conditions such as restless leg syndrome or muscle spasms.
It works by boosting the brain’s levels of gamma-aminobutyric acid (GABA), a relaxing neurotransmitter that can reduce anxiety, stop seizures, and relax tight muscles.
The following table, provided by the FDA, details the lots being added to the voluntary recall, including lot product description and NDC number:
| Potential Product Description / NDC Number | Lot # |
| Clonazepam ODT, USP (C-IV) 2mg / 49884-310-02 | 550176501 |
| 550176601 | |
| Clonazepam ODT, USP (C-IV) 0.125mg / 49884-306-02 | 550174101 |
| Clonazepam ODT, USP (C-IV) 0.25mg / 49884-307-02 | 550142801 |
| 550142901 | |
| 550143001 | |
| 550143101 | |
| 550143201 | |
| 550143301 | |
| 550143401 | |
| 550147201 | |
| 550147401 | |
| Clonazepam ODT, USP (C-IV) 1mg / 49884-309-02 | 550145201 |
| 550175901 | |
| 550176001 | |
| 550176201 |
Also Read: Mental Health: Definition, Types And Strategies To Enhance Well-Being
