Mumbai, April 14: Lupin is voluntarily recalling 9,210 bottles of its antibiotic drug Suprax in the US.
According to the US Food and Drug Administration (USFDA), Lupin Pharmaceuticals Inc, the US-based unit of Lupin, is recalling two lots of Suprax as the “product did not meet specification in total impurities at the nine-month stability station”.
Though the nationwide recall has been initiated by the company on January 27, it has been revealed by the US drug regulator only this week.
The company is recalling 4,038 bottles of Suprax in the first lot and 5,172 bottles of the drug in the second lot. The recall has been initiated under class-III, which the FDA defined as “a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences”.
“This is a voluntary recall initiated on our own and of no business consequence”, a Lupin spokesperson told The Telegraph.
Suprax contains cefixime, which is an oral cephalosporin that has a crucial role in the treatment common infections.
A senior official from a leading pharmaceutical firm said a voluntary recall was a routine phenomenon.
“Being directed to recall a product by the regulator is of a more serious nature,’’ the source added.
However, such recalls by domestic drug companies have drawn attention over the past few months owing to the violation of safety and quality issues. The FDA has become more stringent in its appraisal of drugs from India, the second-largest supplier of generic drugs to the US.
Last month, Ranbaxy recalled more than 64,000 bottles of the generic version of the cholesterol-lowering drug Lipitor.