Ranbaxy Laboratories has recalled from the US market a batch of 4,348 cartons of Sotret Isotretinoin capsules used in treating skin infections.
According to the information available on US health regulator Food and Drug Administration’s (FDA) website, Ranbaxy through its US-based subsidiary Ranbaxy Laboratories Inc, has issued a ‘nation-wide class III recall’ for a batch of Sotret Isotretinoin capsules of 40 mg strength.
The company has issued the recall after ceratin reports suggested that the product may “exceed impurity specifications” during its shelf life period.
However, a class III recall signifies that the use of the product is not likely to be harmful.
This is the second time in last four months that Ranbaxy has initiated a recall. Earlier in July, it had called back a lot of Sotret from the US market.
When contacted the spokesperson of Gurgaon-based firm said this is a Class III recall and is being conducted with the full knowledge of the USFDA.
“Ranbaxy Laboratories Inc, Princeton, New Jersy, is conducting a voluntary recall of Sotret Isotretinoin Capsules, USP 40mg, which is limited to a single batch, currently available in the US market,” the company said.
Asked about the impact of recall on company’s revenues, the company declined to comment over the issue.