The Philippine Food and Drug Administration has recalled a batch of a tuberculosis drug after the drug failed a laboratory test. Test results show the drug had an insufficient amount of one of its active ingredients and it also failed a dissolution test.
According to FDA OIC-Director General Maria Lourdes Santiago, the recalled drug is Onecure, a combination of the drugs Rifampicin, Isoniazid, Pyrazinamide and Ethambutol HCl, batch EZ6369, with an expiration date of December 2016, according to the Manila Bulletin.
The Philippine health regulatory agency warned that “a specific batch of Rifampicin + Isoniazid + Pyrazinamide + Ethambutol HCl 150 mg/ 75 mg/ 400 mg/ 275 mg Film-Coated Tablet (Onecure) is being recalled due to the non-conformance to the specifications of assay and dissolution of the Rifampicin component as reported by the FDA Common Services Laboratory (CSL)-Alabang Testing & Quality Assurance Laboratory.”
Novartis Ltd. in Tongi, Bangladesh manufactures Onecure. The drug is imported to the Philippines by Sandoz Philippines Corporation and distributed by The Generics Pharmacy Inc., the Manila Bulletin reports. Santiago said the drug is used for the management of tuberculosis and for certain mycobacterial infections.
In the same advisory, the Philippine FDA said the principal and identical drug product with the brand name Rimstar 4 and an unbranded product with lot number EZ6369 are being recalled. “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,” the agency warned.
The Philippine FDA advised distributors, retailers, hospitals, pharmacies, and clinics that have the affected batch of Onecure, Rimstar 4, or the generic product with registration number DRP-1751-02 to discontinue further distribution, sale, and use.