Endo USA, Inc, has actually broadened its formerly revealed recall of clonazepam orally breaking down tablets due to a product packaging mistake that might be lethal.
A continuous examination by the business has actually determined the possibility that particular clonazepam item lots consist of containers printed with the inaccurate strength and National Drug Code (NDC) code due to a mistake by a third-party packager.
“Children and grownups who accidentally take in a greater dosage of clonazepam might be at increased threat for the negative occasions of considerable sedation, confusion, lightheadedness, reduced reflexes, ataxia, and hypotonia,” the business stated in the recall statement published today on the United States Food and Drug Administration (FDA) site.
“There is sensible likelihood for substantial, perhaps dangerous, breathing anxiety specifically for clients with concomitant lung illness, clients who have actually recommended dosing near optimum dosing, and clients likewise taking other medications that might trigger extra breathing anxiety,” the business alerted.
Clonazepam (USP, C-IV) is utilized to deal with seizures, panic attack, and stress and anxiety.
The business remembered 2 great deals of clonazepam due to mislabeled containers back in July.
The recall now consists of 16 great deals of the drug. They are:
Prospective Product Description/ NDC NumberLot # Clonazepam ODT 2 mg/ 49884-310-02550176501
550176601
Clonazepam ODT 0.125 mg/ 49884-306-02550174101Clonazepam ODT 0.25 mg/ 49884-307-02550142801
550142901
550143001
550143101
550143201
550143301
550143401
550147201
550147401
Clonazepam ODT 1mg/ 49884-309-02550145201
550175901
550176001
550176201
The remembered clonazepam items are packaged in containers consisting of 60 tablets loaded into 10 blister strips each including 6 tablets.
The container and each blister strip pocket are printed with the name, strength, lot number, expiration date, and NDC number. The blister strips and tablets inside the item pack show the appropriate strength for the lot. The error appears on the item containers.
Action Required
The remembered item lots were dispersed through wholesale suppliers to retail drug stores across the country. Endo looks out wholesale accounts and sellers that have actually gotten the item lots and is scheduling the return of all existing stock through Inmar, Inc.
Customers in belongings of any remembered item ought to instantly stop utilizing it. Any client who unintentionally took an inaccurate dosage instead of the meant dosage ought to call their doctor.
Concerns concerning this recall can be directed to Inmar by telephone at 855-589-1869 (Monday-Friday, 9 AM-5 PM ET) or by e-mail at rxrecalls@inmar.com.
Negative responses or quality issues connected to this recall might be reported to the FDA MedWatch Adverse Event Reporting program.