Ranbaxy Pharmaceuticals Inc, a Florida-based subsidiary of Ranbaxy Laboratories, on Saturday said it is conducting a voluntary recall of the whole lot of nitrofurantoin (monohydrate/m-acrocrystals) capsules, USP 100 mg, currently on the market in the US. The drug is an antibiotic used to cure urinary track 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 media release.
The size of the US sales of the drug being recalled could not be immediately ascertained and a company spokesperson refused to comment. But sources in the company said although the drug was launched in 2005 in the US, it does not have significant sales there.
Ranbaxy had already seen a 14% drop in US sales in the first quarter (Jan-Mar 2009) to Rs 340 crore. Moreover, the pullback comes just months after the company faced USFDA ire on several drugs being manufactured at two of its facilities in India. Following a survey that started in 2006, the USFDA, in 2008 banned 30 drugs manufactured by Ranbaxy at its he Paonta Sahib and Dewas plants for sales in the United States. The USFDA has also put a freeze on sanction of pending and new marketing applications for drugs from these plants.
The withdrawn drug is learnt to have been manufactured from the Paonta Sahib plant.
The recall is being conducted in coordination with the FDA and will be at the retail level. "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," it said. All patients at present consuming and/or prescribed this formulation should consult their physicians for alternate and appropriate medication/treatment options, it added
Ranbaxy, in which Japanese drugmaker Daiichi Sankyo last year bought a controlling 64% stake, had said last week it expected net losses of about Rs 750 crore and a 9% drip in revenue to Rs 7,000 crore.
Ranbaxy Pharmaceuticals Inc is engaged in the sale and distribution of generic and branded prescription products in the US healthcare system. Ranbaxy Labs has ground operations in 49 countries and manufacturing operations in 11 countries. 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.