Ranbaxy Laboratories has begun to voluntary recall of nitrofurantoin (monohydrate/macrocrystals) capsules from the US market, as it does not meet the country’s drug manufacturing standards. The drug is an antibiotic commonly used to treat urinary tract infection.
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 company said in a release here today.
The recall is being conducted in coordination with the Food and Drug Administration (FDA) and will be a retail level recall.
According to the company, 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 like nausea and vomiting.
Ranbaxy has also advised all patients presently using this formulation should to consult their physicians for alternate medication. Florida-based Ranbaxy Pharmaceuticals is a subsidiary of Ranbaxy Laboratories, India’s largest pharmaceutical company.