FDA recalls anti-TB drug

Screengrab from https://www.fda.gov.ph/

MANILA Philippines–The Food and Drug Administration (FDA) has ordered a recall of a specific lot of Rifampicin capsules, a pulmonary tuberculosis drug, because the claim on its label is below the required potency.

In an advisory, the FDA said the recall covered lot no. BK3503 of Rifampicin 450 mg capsules (Picinaf) with registration no. DRP-833 which will expire in July 2015.

“The specific Rifampicin lot presents safety risk and adverse health consequences as it potentially exposes patients to suboptimal doses of Rifampicin therapy,” the advisory said.

Rifampicin is used to treat pulmonary and extrapulmonary tuberculosis. It comes packed in blister packaging containing 10 capsules each in boxes of 100s.

The FDA urged distributors, retailers, hospitals and pharmacies that have the lot no. to discontinue the sale or use of the product.

“All consumers are likewise advised not to purchase or use the affected product,” it added.

The FDA urged the public to report immediately any adverse reactions experienced from using the product.–Tina G. Santos