Batches of medicines for TB, respiratory tract illnesses recalled

MANILA — Several batches of two medicines used for the treatment of tuberculosis and other respiratory tract illnesses are being recalled from the market for failure to meet quality standards, according to the Food and Drug Administration (FDA).

In an advisory, the regulatory agency said Rifampicin (Rifanid) 200 mg/5 mL oral suspension with batch number C4004 and expiry date of November 2017 was ordered pulled out from the market due to “failed pH result from the analysis of the FDA Common Services Laboratory.”

Rifampicin is indicated for treatment of tuberculosis, leprosy, methicillin resistant staphylococcal infections, serious staphylococcal infections, meningococcal carriers and other infections.

In a separate advisory, the FDA announced that Carbocisteine (Oflem) 250 mg/5 mL with lot number 24139 and expiry date of October 2016 was also being recalled from the market due to failed assay result based on laboratory analysis.

The drug is a mucolytic used for the reduction of sputum viscosity to help relieve symptoms of chronic obstructive pulmonary disorder and other respiratory diseases.

“The affected product lot presents safety risks and potential adverse health consequences. Therefore, distributors, retailers, hospitals, pharmacies or clinics that have the affected [products] are instructed to discontinue further distribution, sale and use,” said the FDA.  SFM