Ranbaxy Pharmaceuticals Inc. (RPI) has announced that it is conducting a voluntary recall of all lots of Nitrofurantoin (monohydrate/macrocrystals) capsules, USP 100 mg currently on the market in the United States.
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 US 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.