Ranbaxy recalls Nitrofurantoin capsules

Ranbaxy Pharmaceuticals, a wholly owned subsidiary of Ranbaxy Laboratories, has reported that it is conducting a voluntary recall of all lots of Nitrofurantoin capsules, USP 100mg currently on the market in the US.

Although certain lots of the product were determined to not be in conformity with the approved laboratory specifications, Ranbaxy said that it 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. It is reported that 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, said Ranbaxy. The company urged: all patients presently consuming and/or prescribed this formulation should consult their physicians for alternate and appropriate medication/treatment options.

Ranbaxy Pharmaceuticals based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories Limited. Ranbaxy Pharmaceuticals is engaged in the sale and distribution of generic and branded prescription products in the U.S. healthcare system.