Lupin Pharmaceuticals Inc., a subsidiary of Indian drug maker Lupin Ltd., has initiated a recall of almost 10,000 bottles of an antibiotic product, the U.S. Food and Drug Administration (FDA) has announced.
The recall is voluntary and was initiated on Jan. 27, but it was publicly announced this week. Two lots of Suprax, an antibiotic drug used to treat bacterial infections, are being withdrawn from the U.S. market because the product does not meet federal standards for impurities. Information provided on the FDA's official website states that Lupin is recalling a total of 4,038 bottles of Suprax in the first lot and a further 5,172 bottles in the second lot.
A spokesperson for Lupin in India said that the recall has "no business consequence" but declined any further comment, media reports revealed.
This is not the first time that Suprax has been subject to recall. Last year 64,368 bottles of Suprax were voluntarily recalled in the United States due to discoloration of the product, the Economic Times reported.
Lupin is the fifth-largest generic drug producer in the United States in terms of sales on prescriptions. The U.S. market accounts for about 40 percent of the company's net sales. It is also the fourth biggest generic drug manufacturer in India by market capitalization. The company is the latest Indian pharmaceutical giant that has been hit by increased oversight by the U.S. drug regulator.