Ranbaxy Recalls All Lots of Nitrofurantoin

Cheryl A. Thompson

BETHESDA, MD 05 May 2009—The U.S. subsidiary of Ranbaxy Laboratories Limited on May 2 announced a recall of all lots of nitrofurantoin 100-mg capsules because some do not conform to laboratory specifications.

Ranbaxy Pharmaceuticals Inc. said there is a "remote possibility" that capsules not conforming to the specifications may increase the occurrence of "local non-serious" adverse gastrointestinal events, such as nausea and vomiting, in patients using the product.

The company's nitrofurantoin capsules, containing 25 mg of nitrofurantoin macrocrystals and 75 mg of nitrofurantoin monohydrate, are a therapeutic equivalent of Macrobid capsules, manufactured by Norwich Pharmaceuticals Inc. According to the FDA-approved labeling for Macrobid, the rate of possible or probable drug-related nausea under usual circumstances is 8%. Vomiting is described in the labeling as a symptom of acute overdosage.

Ranbaxy has advised patients who have any of the company's nitrofurantoin capsules to consult their physician for "alternate and appropriate medication/treatment options."