Extra packages of clonazepam, a prescription medicine used to deal with seizures and nervousness, mislabeled with the wrong power have been added to a voluntary recall, in keeping with the U.S. Meals and Drug Administration.
Endo, Inc., the producer of clonazepam, expanded the recall, first introduced in July, to 16 numerous the medicine, in keeping with a recall discover shared by the FDA on Nov. 19.
The recalled product, clonazepam Orally Disintegrating Tablets, is available in cartons, “containing 60 tablets packed into 10 blister strips every containing 6 tablets,” in keeping with Endo.
The affected cartons are printed with the wrong power and Nationwide Drug Code, whereas the blister strips and tablets inside mirror the proper power, in keeping with the corporate, which blamed the error on a “third-party packager.”
A voluntary recall discover for Clonazepam Orally Disintegrating Tablets was expanded on Nov. 19, 2024, by Endo, Inc.
Handout/Endo, Inc.
Each Endo’s and the FDA’s recall notices embrace the checklist of affected lot numbers, that are additionally seen on the product packaging.
The packaging of recalled merchandise says “Distributed by: Par Pharmaceutical,” which marketed clonazepam earlier than it was acquired by Endo, in keeping with the corporate.
Customers with a recalled bundle are suggested to “discontinue use” of the product.
A voluntary recall discover for Clonazepam Orally Disintegrating Tablets was expanded on Nov. 19, 2024, by Endo, Inc.
Handout/Endo, Inc.
If a client is worried they could have taken an incorrect dose of clonazepam, they’re suggested by Endo to “seek the advice of a doctor.”
In keeping with Endo, no antagonistic occasions have been reported to this point in relation to the recalled merchandise.
The corporate warns that kids and adults who take an incorrect dose of clonazepam are in danger for an antagonistic response.
“Youngsters and adults who inadvertently devour a better dose of clonazepam might be at elevated danger for the antagonistic occasions of serious sedation, confusion, dizziness, diminished reflexes, ataxia, and hypotonia,” Endo mentioned within the recall discover. “There may be affordable likelihood for important, 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 drugs that would trigger further respiratory despair.”
The recalled merchandise had been distributed nationwide in keeping with Endo, which mentioned it’s working with one other firm, Inmar, Inc., to have all the present stock of affected merchandise returned.
Customers might contact Inmar with questions by electronic mail at rxrecalls@inmar.com and by phone at 855-589-1869, Monday by way of Friday, 9 a.m. to five p.m. ET.
Clonazepam, in a category of medicines known as benzodiazepines, works by, “reducing irregular electrical exercise within the mind,” in keeping with the U.S. Nationwide Library of Drugs.
The drug is used to assist management sure forms of seizures and to assist relieve panic assaults. It’s sometimes taken one to 3 instances a day with or with out meals, in keeping with the NLM.
