Ranbaxy recalls Nitrofurantoin capsules in the US

In its second drug recall in the US market since 2007, Ranbaxy Pharmaceuticals Inc, the US subsidiary of Ranbaxy  yesterday disclosed tht it was recalling all lots of its Nitrofurantoin (monohydrate / nacrocrystals) capsules, an antibacterial agent specific for urinary tract infections, from pharmacy outlets in the US market.

Earlier in November 2007, Ranbaxy had recalled 73 million tablets of gabapentin tablets after the impurities content in the drug exceeded the permissible limits.

Ranbaxy is withdrawing all lots of its Nitrofurantoin in 100mg doages in the US, saying, that 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 also said that it 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 said in a regulatory filing, "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." the company has cautioned.

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 US healthcare system.