IGMPI India

Lupin issued a voluntary recall of 9,210 bottles of its antibiotic drug Suprax, used to treat bacterial infections, in the US market. The company has also recalled nearly 10,000 bottles of one of its antibacterial drugs after finding that the product did not meet purity standards set by the US Food and Drug Administration (FDA).

According to US FDA, Lupin Pharmaceuticals Inc, the US-based unit of the company, initiated the recall of two lots of Suprax as the “product did not meet specification in total impurities at the nine-month stability station”. The company has recalled 4,038 bottles of Suprax in the first lot and 5,172 bottles of the drug in the second lot in the US market. Suprax contains Cefixime, which is a third-generation oral cephalosporin that has an important role in treating common infections. The drug is used to treat bacterial infections of the ear and upper respiratory tract. The FDA classified the recall as “Class III” recall which indicates as "a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences". In the previous year also, Mumbai based firm had voluntarily recalled 64,368 bottles of Suprax in the US market on account of discoloration.

The antibacterial drug, Ethambutol Hydrochloride tablets, with pills of 400 mg and in bottles of 100-count has also been recalled. The drug is manufactured in India but distributed by Lupin Pharmaceuticals, which is based in Baltimore. The drug is recalled as it failed impurities and degradation specifications.