The anxiety-reducing drug, Clonazepam, has been recalled after a probably “life-threatening” label mix-up, the Meals and Drug Administration (FDA) mentioned.
In keeping with a launch from the federal company, Endo Inc. introduced a voluntary recall of 16 a lot of Clonazepam Orally Disintegrating Tablets.
The pharmaceutical firm mentioned the fast recall got here after it was found that 16 a lot of the anxiousness drug have been mislabeled with the wrong energy and Nationwide Drug Code (NDC) on them. The corporate mentioned the labeling error was made by a third-party packager.
In consequence, kids and adults prescribed Clonazepam might face “life-threatening” uncomfortable side effects, the FDA warned.
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The recalled merchandise have been distributed to pharmacies nationwide in cartons containing 60 tablets packed into 10 blister strips of six tablets. (FDA)
The mislabeling of the drug might lead to “vital sedation, confusion, dizziness, diminished reflexes, ataxia, and hypotonia,” the FDA mentioned.
“There may be cheap chance for vital, presumably life-threatening, respiratory despair particularly for sufferers with concomitant pulmonary illness, sufferers who’ve prescribed dosing close to maximal dosing, and sufferers additionally taking different medicines that would trigger extra respiratory despair,” the FDA mentioned.
Endo Inc. famous that, as of Nov. 21, there haven’t been any experiences of adversarial results from the product recall.
The corporate mentioned the labeling error was made by a third-party packager. (FDA)
The next desk, offered by the FDA, particulars the heaps being added to the voluntary recall, together with lot product description and NDC quantity:
| Potential Product Description / NDC Quantity | 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 |
People with unused prescribed pill cartons of Clonazepam Orally Disintegrating tablets bearing the above lot numbers have been suggested to discontinue use of the product.
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Within the occasion {that a} affected person inadvertently took an incorrect dose somewhat than the supposed dose, they’re suggested to seek the advice of a doctor, the FDA mentioned.
Shoppers with questions in regards to the recall can contact Inmar Inc., the corporate dealing with the recollects, by phone at 855-589- 1869 or by electronic mail at rxrecalls@inmar.com.
Signage is seen exterior the Meals and Drug Administration (FDA) headquarters in White Oak, Maryland. (REUTERS/Andrew Kelly/File Picture)
Clonazepam tablets deal with seizures and may also be used to deal with panic dysfunction, in keeping with the Cleveland Clinic.
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“It really works by serving to your nervous system relax,” the Cleveland Clinic mentioned. “It belongs to a gaggle of medicines known as benzodiazepines.”
