Popular anxiety drug, Clonazepam, recalled nationwide for ‘potentially life-threatening’ error
The anti-anxiety drug, Clonazepam, has been recalled after a potentially “health-threatening” label combination, the Food and Drug Administration (FDA) said.
According to a release from the federal agency, Endo Inc. announced a voluntary recall of 16 Clonazepam Orally Disintegrating tablets.
The pharmaceutical company said the immediate withdrawal came after it was discovered that a number of the drugs of concern were mislabeled with the wrong strength and National Drug Code (NDC) on them. The company said the labeling error was made by a third-party packager.
As a result, children and adults who are prescribed Clonazepam can experience “life-threatening” side effects, the FDA warned.
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The recalled products were distributed to pharmacies across the country in boxes containing 60 tablets packed in 10 blister strips of six tablets. (FDA)
Misprescribing the drug can cause “severe lethargy, confusion, dizziness, cognitive decline, ataxia, and hypotonia,” the FDA said.
“There is a reasonable chance of severe, potentially life-threatening respiratory distress, particularly in patients with underlying lung disease, patients who have overdosed, and patients taking other medications that may cause additional respiratory distress,” the FDA said.
Endo Inc. noted that, as of Nov. 21, there have been no reports of adverse effects from the product recall.
The company said the labeling error was caused by a third-party package. (FDA)
The following table, provided by the FDA, details the lots added to the voluntary recall, including a description of the lot and the NDC number:
| Potential product description / NDC number | Part # |
| 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 |
Individuals with cartons of unused prescription tablets of Clonazepam Oral Disintegrating Tablets with the above numbers have been advised to discontinue use of the product.
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In the event that the patient took the wrong dose instead of the intended dose, it is advised to consult a doctor, the FDA said.
Consumers with questions about the recall can contact Inmar Inc., the company handling the recall, by phone at 855-589-1869 or by email at rxrecalls@inmar.com.
Signs are visible outside the Food and Drug Administration (FDA) headquarters in White Oak, Maryland. (REUTERS/Andrew Kelly/File Photo)
Clonazepam tablets treat seizures and can also be used to treat panic attacks, according to Cleveland Clinic.
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“It works by helping your nervous system calm down,” says the Cleveland Clinic. “It belongs to a group of drugs called benzodiazepines.”
