Lupin recalls 9,000 bottles of antibiotic drug Suprax in US
According to information available on the US Food and Drug Administration’s (FDA’s)website, Lupin Pharmaceuticals Inc, is recalling two lots of Suprax as the 'product did not meet specification in total impurities at the nine-month stability station'.business Updated: Apr 15, 2014 01:57 IST
In the latest blow to Indian pharma, Mumbai-based drug maker Lupin has voluntarily recalled over 9,000 bottles of its antibiotic drug Suprax in the US market.
According to information available on the US Food and Drug Administration’s (FDA’s)website, Lupin Pharmaceuticals Inc, the US-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 US market, the FDA said.
The drug is used to treat bacterial infections of the ear and upper respiratory tract.
The company has termed this as voluntary recall. “This is a voluntary recall initiated on our own and of no business consequence,” a Lupin spokesperson said without giving any further details.
Lupin, according to the market estimates, earns 40% of its net sales from the US. The nationwide recall has been initiated by the company on January 27 this year.
The latest incident adds to the list of mess-ups happening between US and India in the pharma sector. Recently, Ranbaxy Laboratories had to issue a recall of generic versions of cholesterol drug Lipitor in the US. Another drug maker, Sun Pharmaceutical, also recalled thousands of bottles of generic diabetes medication in the US this year.