The recalled product, an oral suspension containing amoxicillin and clavulanate potassium used for the treatment of childhood ear infections, is being withdrawn after reports that it turns brown rather than white on reconstitution.
According to a report in the Wall Street Journal, the drug is made at Ranbaxy’s facility in Dewas which is currently the subject of a US Food and Drug Administration (FDA) import ban.
A Ranbaxy spokesperson told the paper that drug, which was not covered by the import ban, was being recalled as a precautionary measure “with the full knowledge of the FDA.”
