The anxiety-reducing drug clonazepam has been recalled following a potentially “life-threatening” label mix-up, the Food and Drug Administration (FDA) announced.
According to release Following notification from a federal agency, Endo Inc. has announced a voluntary recall of 16 lots of clonazepam orally disintegrating tablets.
The drug company said the immediate recall was carried out after 16 lots of the anti-anxiety drug were found to have been incorrectly labeled with the wrong strength and National Drug Code (NDC). The company said the labeling error was made by a third-party packager.
As a result, children and adults prescribed clonazepam may face “life-threatening” side effects, the FDA warned.
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The recalled product was distributed to pharmacies nationwide in cartons containing 60 tablets packed in 10 blister strips of six tablets each. (FDA)
The FDA said the drug’s mislabeling can cause “significant sedation, confusion, dizziness, decreased reflexes, ataxia, and hypotonia.”
“This can be a serious, possibly life-threatening condition, especially in patients with preexisting pulmonary disease, prescribed near-maximal doses, or who are also taking other medications that can cause further respiratory depression. “Threatening respiratory depression is likely to occur,” the FDA said.
Endo Co., Ltd. says that as of November 21, there have been no reports of adverse effects from the product recall.
The company said the labeling error was made by a third-party packager. (FDA)
The following table provided by FDA provides details for lots added to the voluntary recall, including the lot’s product description and NDC number.
| Potential product description/NDC number | Many # |
| 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 |
Anyone with an unused prescription tablet carton of Clonazepam orally disintegrating tablets with the lot number listed above is advised to discontinue use of the product.
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The FDA said it recommends that patients contact their doctor if they accidentally take the wrong dose instead of the intended dose.
Consumers with questions about the recall can contact Inmar Inc., the company responsible for the recall, by phone at 855-589-1869 or by email. [email protected].
A sign can be seen outside the Food and Drug Administration (FDA) headquarters in White Oak, Maryland. (Reuters/Andrew Kelly/File Photo)
According to , clonazepam tablets not only treat seizures, but can also be used to treat panic disorder. cleveland clinic.
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“It helps calm the nervous system,” the Cleveland Clinic said. “It belongs to a group of drugs called benzodiazepines.”
