India’s leading drug maker Ranbaxy has initiated a voluntary recall of 4,348 cartons of its skin infection drug Sotret (isotretinoin) in the United States. The entire lot pertains to a single batch of tablets which were found to be ‘out of specification’.
This is the second instance in four months when Ranbaxy has initiated a recall. In July, the company had pulled out a lot of Sotret from the US market after it was found to be degraded. Confirming the development, a company spokesperson said the recall was carried out voluntarily and was limited to a single lot of Sotret 40 mg tablets.
According to the US Food and Drugs Administration (USFDA), the recall comes under the Class III category, which implies that the use of or exposure to the product that is being recalled is unlikely to have any adverse health impact.