The anxiety-reducing drug, Clonazepam, has been recalled after a doubtlessly “life-threatening” label mix-up, the Meals and Drug Administration (FDA) stated.
In line with a release from the federal company, Endo Inc. introduced a voluntary recall of 16 plenty of Clonazepam Orally Disintegrating Tablets.
The pharmaceutical firm stated the rapid recall got here after it was found that 16 plenty of the anxiousness drug have been mislabeled with the wrong energy and Nationwide Drug Code (NDC) on them. The corporate stated the labeling error was made by a third-party packager.
In consequence, youngsters and adults prescribed Clonazepam might face “life-threatening” negative 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 end in “vital sedation, confusion, dizziness, diminished reflexes, ataxia, and hypotonia,” the FDA stated.
“There may be affordable chance for vital, probably life-threatening, respiratory despair particularly for sufferers with concomitant pulmonary disease, sufferers who’ve prescribed dosing close to maximal dosing, and sufferers additionally taking different drugs that might trigger extra respiratory despair,” the FDA stated.
Endo Inc. famous that, as of Nov. 21, there haven’t been any experiences of adversarial results from the product recall.
The corporate stated the labeling error was made by a third-party packager. (FDA)
The next desk, supplied by the FDA, particulars the tons 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 slightly than the supposed dose, they’re suggested to seek the advice of a doctor, the FDA stated.
Customers 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 e 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 will also be used to deal with panic dysfunction, in response to the Cleveland Clinic.
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“It really works by serving to your nervous system relax,” the Cleveland Clinic stated. “It belongs to a bunch of medicines referred to as benzodiazepines.”