The anxiety-reducing drug, Clonazepam, has been recalled after a probably “life-threatening” label mix-up, the Meals and Drug Administration (FDA) stated.
In keeping with a launch from the federal company, Endo Inc. introduced a voluntary recall of 16 plenty of Clonazepam Orally Disintegrating Tablets.
The pharmaceutical firm stated the instant recall got here after it was found that 16 plenty of the nervousness drug had been mislabeled with the inaccurate power and Nationwide Drug Code (NDC) on them. The corporate stated the labeling error was made by a third-party packager.
Because of this, youngsters and adults prescribed Clonazepam might face “life-threatening” unwanted effects, the FDA warned.
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The recalled merchandise had 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 stated.
“There’s cheap chance for vital, probably 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 drugs that would trigger further 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 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 moderately than the meant dose, they’re suggested to seek the advice of a doctor, the FDA stated.
Shoppers with questions concerning the recall can contact Inmar Inc., the corporate dealing with the remembers, by phone at 855-589- 1869 or by e-mail at rxrecalls@inmar.com.
Signage is seen outdoors 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 response to the Cleveland Clinic.
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“It really works by serving to your nervous system settle down,” the Cleveland Clinic stated. “It belongs to a gaggle of medicines known as benzodiazepines.”