The anxiety-reducing drug, Clonazepam, has been recalled after a probably “life-threatening” label mix-up, the Meals and Drug Management (FDA) mentioned.
In step with a release from the federal company, Endo Inc. introduced a voluntary recall of 16 quite a lot of Clonazepam Orally Disintegrating Capsules.
The pharmaceutical corporate mentioned the speedy recall got here after it was once found out that 16 quite a lot of the anxiousness drug have been mislabeled with the flawed power and Nationwide Drug Code (NDC) on them. The corporate mentioned the labeling error was once made by means of a third-party packager.
Consequently, kids and adults prescribed Clonazepam may just face “life-threatening” unwanted side effects, the FDA warned.
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The recalled merchandise have been disbursed to pharmacies national in cartons containing 60 capsules packed into 10 blister strips of six capsules. (FDA)
The mislabeling of the drug may just lead to “vital sedation, confusion, dizziness, lowered reflexes, ataxia, and hypotonia,” the FDA mentioned.
“There’s cheap likelihood for vital, perhaps life-threatening, respiration despair particularly for sufferers with concomitant pulmonary disease, sufferers who’ve prescribed dosing close to maximal dosing, and sufferers additionally taking different medicines that would motive further respiration despair,” the FDA mentioned.
Endo Inc. famous that, as of Nov. 21, there have no longer been any stories of inauspicious results from the product recall.
The corporate mentioned the labeling error was once made by means of a third-party packager. (FDA)
The next desk, supplied by means of the FDA, main points the quite a bit being added to the voluntary recall, together with lot product description and NDC quantity:
| Doable 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 capsules bearing the above lot numbers were suggested to discontinue use of the product.
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Within the match {that a} affected person inadvertently took an flawed dose slightly than the supposed dose, they’re suggested to seek the advice of a doctor, the FDA mentioned.
Customers with questions in regards to the recall can touch Inmar Inc., the corporate dealing with the recollects, by means of phone at 855-589- 1869 or by means of e-mail at rxrecalls@inmar.com.
Signage is observed outdoor the Meals and Drug Management (FDA) headquarters in White Oak, Maryland. (REUTERS/Andrew Kelly/Report Photograph)
Clonazepam capsules deal with seizures and may also be used to regard panic dysfunction, in keeping with the Cleveland Clinic.
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“It really works by means of serving to your worried gadget chill out,” the Cleveland Health center mentioned. “It belongs to a bunch of medicines referred to as benzodiazepines.”
