India's Lupin Recalls Antibiotic in U.S.

Apr 14, 2014

Wall Street Journal

Mumbai-based drugmaker Lupin is recalling ten thousand bottles of its Suprax antibacterial drugs after finding that they failed to meet U.S. standards for impurities.

The recall is being handled through Lupin's sales and marketing headquarters in Baltimore, MD. Suprax, the brand name for cefixime, is an antibiotic used to treat bacterial infections of the ear and upper respiratory tract.

According to the WSJ, the recall was initiated on Jan 27 but was not made public by the FDA until April 9 when Lupin was reported for, "failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station."

This recall comes on the heels of numerous compliance issues faced by Indian drugmakers, including the FDA's ban on imports from major Indian players Sun Pharmaceutical, Ranbaxy and Wockhardt.

Read the WSJ story