Ranbaxy recalls Nitrofurantoin Capsules from US

MUMBAI: Ranbaxy Laboratories, leading drug manufacturer, has voluntarily started recall of all lots of Nitrofurantoin Capsules. It is learnt that the company has to do this as it does not meet the US drug manufacturing standards. The capsules are used in treatment of infections. In a filing to the Bombay Stock Exchange on Saturday, Ranbaxy Labs said that Ranbaxy Pharmaceutical Inc (RPI), a subsidiary of Ranbaxy Laboratories, India’s largest pharmaceutical company, has begun to recall all lots of Nitrofurantoin (Monohydrate/Macrocrystals) Capsules, United States Pharmacopeia (USP) 100 mg, available in the market there.

Ranbaxy Pharmaceuticals Inc is engaged in the sale and distribution of generic and branded prescription products in the US. It is to be mentioned here that USP is an official public standards -- setting authority for all prescription and over-the-counter medicines and other health care products manufactured or sold in the US.

The filing stated that although certain lots of the products were determined to not be in conformity with the approved laboratory specifications, the company decided to recall all the lots, as a matter of abundant caution. The recall is being conducted in coordination with the Food and Drug Administration (FDA) and will be a retail level recall.