FDA Recalls Anti Tuberculosis Drug OnecureMay 3, 2016
Tuberculosis, a disease usually affecting the lungs, is a bacterial infection that spreads when small droplets are released through the air by coughs or sneezes. Tuberculosis requires extensive medicinal treatment to eradicate the infection, according to the Mayo Clinic.
Onecure, a combination of Rifampicin, Isoniazid, Pyrazinamide and Ethambutol HCI, is a combination drug used for the treatment of tuberculosis. It has been recalled by the U.S. Food and Drug Administration (FDA). A specific batch of this drug has been recalled with an expiration date of December 2016.
The OIC-Director General Maria Lourdes Santiago said Onecure is used in the treatment of tuberculosis and in certain mycobacterial infections. Onecure is manufactured by Novartis, Bangladesh, Ltd. Imported in the Philippines by Sandoz Philippines Corporation and is distributed by The Generics Pharmacy Inc., reported the FDA.
The FDA, in the same warning, said that the principal and identical drug product with the name Rimstar 4 and an unbranded product with lot number EZ6369 was also subject to recall.
“The affected product batch presents safety risk, therapeutic failure, and consequent antimicrobial resistance due to the insufficient amount of Rifampicin present and anticipated problem with the release of the said active pharmaceutical ingredient from the dosage form," warned the FDA.
The FDA has advised that distribution, sale, or use, of the affected batch of Onecure, Rimstar 4, and another generic product with the registration number DjRP-1751-02 by all hospitals, pharmacies, or clinics, be discontinued.