The Philippines Food and Drug Administration (FDA) announced the recall of the anti-tuberculosis drug, Onecure, after one component of the drug failed specifications.
Onecure, which is manufactured by Novartis Ltd. in Tongi, Bangladesh, imported in the Philippines by Sandoz Philippines Corporation and distributed by The Generics Pharmacy Inc., is a combination of Rifampicin, Isoniazid, Pyrazinamide and Ethambutol HCl.
They affected batch, EZ6369 with an expiration of Dec. 2016, was 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.
“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,” according to the FDA.
In addition, the principal and identical drug product with the brand name Rimstar 4 and an unbranded product with lot number EZ6369 are being subjected to recall.
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