Suprax Infection Prevention Drugs Recalled

On April 14, 2014, Indian pharmaceutical company Lupin announced a voluntary recall of 9,210 bottles of Suprax, a drug used to treat bacterial infection. According to the U.S. Food and Drug Administration, the medication failed purity tests done in the United States and were not eligible for sale here. However, this is a class III recall, meaning there have been no adverse health consequences. Suprax is typically prescribed for ear infections, sinusitis, tonsillitis, strep throat, bronchitis, and pneumonia; so it is a common drug in the U.S.

This is not the first time that drugs produced by Lupin have been recalled over a purity issue. In January 2013, more than 65,000 bottles of Suprax were pulled from shelves in the U.S. over a discoloration issue. In September of that year, the company recalled 53,000 bottles of Quinapril, a drug used to treat high blood pressure.

Indian pharmaceutical companies produce up to 40 percent of drugs sold in the United States, and in recent months the FDA has been more closely scrutinizing medications produced by these manufacturers. There have been several high-profile recalls from the country, including a recall of more than 500,000 bottles of Lipitor made by Ranbaxy Laboratories. Several companies that compete with Lupin, Ranbaxy Laboratories Ltd., Sun Pharmaceutical Industries Ltd. and Dr. Reddy’s Laboratories Ltd., have also had high-profile recalls for products sold in the U.S. And earlier this year, the FDA completely banned imports of prescription drugs from Indian-based Sun Pharmaceuticals.

While no health effects have been reported in connection with those recalls, several American drug companies express concerns that Indian-made generic drugs are not as effective as the domestic name-brand versions. Problems like these may spell big trouble for Lupin, which relies on the U.S. for approximately 40 percent of its total sales since its initial entry into the market in 2003.

Since the recall occurred before these products hit shelves, there’s no reason for consumers to be concerned. However, if you are prescribed Suprax or another recalled drug, confirm with your pharmacist that the batch you are given has passed through quality control.

Sources:
http://www.reuters.com/article/2014/04/15/usa-lupin-suprax-idUSL3N0N71MM20140415
http://www.fiercepharma.com/story/lupin-recalls-more-suprax-purity-problems-adding-indian-pharmas-quality-que/2014-04-14