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Drug major Lupin is voluntarily recalling 9,210 bottles of its antibiotic drug Suprax, used to treat bacterial infections, in the US market, according to the US Food and Drug Administration (USFDA).
According to information available on the USFDA Web site, Lupin Pharmaceuticals Inc, the US-based unit of the company, is recalling two lots of Suprax as the “product did not meet specifications on 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 US market, it added.
The nationwide recall was initiated 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 US market on account of discolouration.
Suprax contains cefixime, which is a third-generation oral cephalosporin that has an important role in treating common infections.
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