FDA recalls antibacterial drug

MANILA, Philippines - The Food and Drug Administration (FDA) has ordered the immediate pullout of an antibacterial drug from the local market.

Acting FDA director general Dr. Kenneth Hartigan-Go said Clarie DS 250 (generic name clarithromycin) for oral suspension with batch number CQSIC302E has been recalled.

He said that in the laboratory, Clarie DS 250 failed to meet specifications even after FDA testers followed the direction for reconstitution stated on the label. The FDA chief said the drug presents a safety risk – it could cause adverse health consequences due to “above limit content.” 

Hartigan-Go ordered all retail outlets “carrying all batches” of Clarie DS 250, manufactured by Ind-Swift Limited-India, “to discontinue selling or offering (them) for sale to consumers.” He also advised doctors not to prescribe the drug.

The FDA directed Ambica International Trading Corp., the importer, distributor and license holder of Clarie DS 250, to put on “hold” all batches of the product.