FDA recalls anti-TB drug

MANILA, Philippines - The Food and Drug Administration (FDA) has recalled an anti-tuberculosis drug from the local market.

In an advisory issued yesterday, the FDA said “all consumers are advised not to purchase or use” Picinaf (generic name rifampicin) 450-milligram capsules because laboratory analysis showed them to be below the required potency and would expose patients to a suboptimal dose of the drug.

Picinaf, manufactured by J.M. Tolmann Laboratories Inc. and distributed by Generics Pharmacy, presents a safety risk and possible adverse consequences to consumers.

According to the FDA, rifampicin is used for the treatment of pulmonary and extra-pulmonary tuberculosis.

The FDA ordered distributors, retailers, hospitals, pharmacies and clinics to discontinue the further use or sale of the product.

The agency also ordered its field officers to monitor the availability of the product in the market.

Show comments