Ranbaxy recalls Nitrofurantoin capsules in US
Ranbaxy Pharmaceuticals Inc (RPI) is conducting a voluntary recall of all lots of Nitrofurantoin (monohydrate/macrocrystals) 100mg capsules currently for sale in the US.
Ranbaxy Pharmaceuticals Inc (RPI) is conducting a voluntary recall of all lots of Nitrofurantoin (monohydrate/macrocrystals) 100mg capsules currently for sale in the US.
Although some product lots did not conform to the approved laboratory specifications, Ranbaxy has decided to recall all batches as a matter of caution. The company is continuing to look into the cause of the non-conformity.
The retail level recall is being conducted in coordination with the FDA. Ranbaxy said to the best of its knowledge, the recalled product was unlikely to produce any serious adverse health effects. However, there is a remote possibility that the non-conforming product may increase local non-serious gastrointestinal adverse events such as nausea and vomiting. The company advises all patients presently consuming and/or prescribed this formulation to consult their doctors for alternative medication options.
RPI, based in Jacksonville, Florida, is a wholly owned subsidiary of Ranbaxy Laboratories, India's largest pharmaceutical company. RPI distributes generic and branded prescription products in the US.