Princeton-based US subsidiary of the largest India-based drug maker, Ranbaxy Laboratories Ltd, has voluntarily recalled a single batch of skin infection drug Sotret Isotretinoin capsules of 40mg strength from the US market. “Ranbaxy Laboratories Inc, Princeton, NJ, is conducting a voluntary recall of Sotret Isotretinoin Capsules, USP 40mg, which is limited to lot no 1876846 currently available in the US market,” a company spokesperson said.
The company official said that the move to withdraw this lot of medicines fell under the US Food and Drug Administration’s (US FDA) Class III recall. Such a recall, according to the US FDA, implies that the use of or exposure to the product is not likely to cause adverse health consequences.
The company added that the recall was being conducted with the full knowledge of the US FDA. While Ranbaxy tested the lot in question and found it to be in conformity with the requisite product specifications, it is at the behest of the US FDA’s testing and recommendation that the company has recalled the product batch. “While Ranbaxy tested the lot in question and found it to be within specifications, based on the US FDA’s testing and recommendation, and out of an abundance of caution given Ranbaxy’s commitment to the health and safety of patients, a recall has been initiated to the wholesaler/distributor level,” said the spokesperson. Ranbaxy got the US FDA approval to market the drug in 2003 and the company has an annual sale of around $415 million in the US. Earlier this year, Ranbaxy had voluntarily recalled urinary tract infection drug Nitrofurantoin (100 mg capsules) from the US market after it was found that the drugs did not meet the US drug manufacturing standards. “Although certain lots of the product were determined to not be in conformity with the approved laboratory specifications, Ranbaxy decided to recall all the lots, as a matter of abundant caution, given its commitment to the health and safety of patients. Ranbaxy is continuing to look into the cause of such non-conformity,” a Ranbaxy statement had said then.
In November 2007, it had recalled 73 million gabapentin tablets after the impurities content in the drug exceeded the permissible limits.