New Delhi: Pharma major Ranbaxy Laboratories on Thurday said its US-based subsidiary, Ranbaxy Laboratories Inc Priceton NJ, is recalling capsules used in the treatment of acne (a type of skin disease) from the US market.
“Ranbaxy Laboratories Inc Priceton NJ is conducting a voluntary recall of Sotret Isotretinoin capsules, USP 40 mg, which is limited to Lot No 1876849, currently available in the US market,” a Ranbaxy spokesperson told the agency.
While Ranbaxy tested the lot in question and found it to have met the specified standards, it is recalling the product on the US health regulator Food and Drug Administration’s (FDA’s) recommendation, the company said.
“... based on the US FDA’s testing and recommendations, and out of an abundance of caution, ... a recall has been initiated to the wholesaler/distributor level,” the firm said.
However, the company clarified that this is a class III recall, which signifies that the use or exposure to the product is not likely to cause adverse effects.
“The recall is being conducted with the full knowledge of the US FDA,” the company said.
Ranbaxy got the USFDA nod to market the drug in 2003 and it has an annual sale of around $415 million in the US.