Ranbaxy's US subsidiary recalls anti-acne drug from US market

Ranbaxy Laboratories, now controlled by Tokyo-based Daiichi Sankyo Co. Ltd., has recalled its skin care capsule Sotret Isotretinoin from the US market at the recommendation of the US Food and Drug Administration (USFDA), the company said yesterday.

The capsule, used in the treatment of acne, is believed to be one of the big products for Ranbaxy. According to pharma experts, this will be one of the top five products that Ranbaxy has in the US market and analysts expect the recall to have a negative impact on the company's balance sheet and brand.

The US market accounts for about a quarter of Ranbaxy's $1.5-billion global revenues.

The drug was approved by FDA in 2002 and was reported to occupy one-third of the market in 2007. It had been allowed to be sold in the market as it was not unsafe, but later figured  among the 30 Ranbaxy drugs banned by FDA in September 2007, after failing a test for its efficacy, uniformity and stability.

According to estimates, the likely loss to the company could be at at $1 million. The sales from the drug have been around $50 million per annum.

Ranbaxy recalled 1,303 cartons of the drug with effect from June 26. Ranbaxy said the recalled lot - No.1876846 - is within US FDA specifications and the company's move was more due to "caution".