Ranbaxy Voluntarily Recalls Nitrofurantoin Capsules in the U.S.

PRINCETON, N.J., May 1 /PRNewswire/ -- Ranbaxy Pharmaceuticals Inc. (RPI) announced today that it is conducting a voluntary recall of all lots of Nitrofurantoin (Monohydrate/Macrocrystals) Capsules, USP 100 mg currently on the market in the U.S.

Although certain lots of the product were determined to not be in conformity with the approved laboratory specifications, Ranbaxy decided to recall all the lots, as a matter of abundant caution, given its commitment to the health and safety of patients. Ranbaxy is continuing to look into the cause of such non-conformity.

The recall is being conducted in coordination with the FDA and will be a retail level recall. To the best of Ranbaxy's knowledge, the recalled product is unlikely to produce any serious adverse health effects. However, there is a remote possibility that the non-conforming product may increase the incidence of local non-serious gastrointestinal adverse events such as nausea and vomiting. All patients presently consuming and/or prescribed this formulation should consult their physicians for alternate and appropriate medication/treatment options.

Ranbaxy Pharmaceuticals Inc. (RPI) based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India's largest pharmaceutical company. RPI is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.

Source: Ranbaxy Pharmaceuticals Inc.

CONTACT: Edwige Buteau, edwige.buteau@rfbinder.com, +1-212-994-7517, or Caroline Dickson, caroline.dickson@rfbinder.com, +1-212-994-7560

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Posted: May 2009


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