The anxiety-reducing drug, Clonazepam, has been recalled aft a perchance "life-threatening" statement mix-up, the Food and Drug Administration (FDA) said.
According to a release from the national agency, Endo Inc. announced a voluntary callback of 16 tons of Clonazepam Orally Disintegrating Tablets.
The pharmaceutical institution said the contiguous callback came aft it was discovered that 16 tons of the anxiousness cause were mislabeled with the incorrect spot and National Drug Code (NDC) connected them. The institution said the labeling mistake was made by a third-party packager.
As a result, children and adults prescribed Clonazepam could look "life-threatening" broadside effects, the FDA warned.
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The recalled products were distributed to pharmacies nationwide successful cartons containing 60 tablets packed into 10 blister strips of six tablets. (FDA)
The mislabeling of the cause could effect successful "significant sedation, confusion, dizziness, diminished reflexes, ataxia, and hypotonia," the FDA said.
"There is tenable probability for significant, perchance life-threatening, respiratory slump particularly for patients with concomitant pulmonary disease, patients who person prescribed dosing adjacent maximal dosing, and patients besides taking different medications that could origin further respiratory depression," the FDA said.
Endo Inc. noted that, arsenic of Nov. 21, determination person not been immoderate reports of adverse effects from the merchandise recall.
The institution said the labeling mistake was made by a third-party packager. (FDA)
The pursuing table, provided by the FDA, details the tons being added to the voluntary recall, including batch merchandise statement and NDC number:
Potential Product Description / NDC Number | 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 |
Individuals with unused prescribed tablet cartons of Clonazepam Orally Disintegrating tablets bearing the supra batch numbers person been advised to discontinue usage of the product.
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In the lawsuit that a diligent inadvertently took an incorrect dose alternatively than the intended dose, they are advised to consult a physician, the FDA said.
Consumers with questions astir the callback tin interaction Inmar Inc., the institution handling the recalls, by telephone astatine 855-589- 1869 oregon by email astatine rxrecalls@inmar.com.
Signage is seen extracurricular the Food and Drug Administration (FDA) office successful White Oak, Maryland. (REUTERS/Andrew Kelly/File Photo)
Clonazepam tablets dainty seizures and tin besides beryllium utilized to dainty panic disorder, according to the Cleveland Clinic.
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"It works by helping your tense strategy calm down," the Cleveland Clinic said. "It belongs to a radical of medications called benzodiazepines."
Sarah Rumpf-Whitten is simply a breaking quality writer for Fox News Digital and Fox Business.
Story tips and ideas tin beryllium sent to sarah.rumpf@fox.com and connected X: @s_rumpfwhitten.