Drug major Lupin is voluntarily recalling 9,210 bottles of its antibiotic drug Suprax, used to treat bacterial infections, in the U.S. market, according to the U.S. Food and Drug Administration (USFDA).
As per the information available on the USFDA website, Lupin Pharmaceuticals Inc., the U.S.-based unit of the company, is recalling two lots of Suprax as the “product did not meet specification in total impurities at the nine-month stability station”.
The company is recalling 4,038 bottles of Suprax in the first lot, and 5,172 bottles of the drug in the second lot in the U.S. market, it added. The nation-wide recall has been initiated by the company on January 27 this year.
The recall of the drugs has been initiated under Class-III, which FDA defined as “a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences“.
When contacted, a Lupin spokesperson said: “This is a voluntary recall initiated on our own and of no business consequence.”
Last year also, the Mumbai-based firm had voluntarily recalled 64,368 bottles of Suprax in the U.S. market on account of discolouration.
Suprax contains cefixime, which is a third-generation oral cephalosporin that has an important role in treating common infections.