Ranbaxy to recall antibiotic drug from US marketMay 2nd, 2009 - 7:39 pm ICT by IANS
Mumbai, May 2 (IANS) Leading drug maker Ranbaxy Laboratories Saturday said it will recall all lots of Nitrofurantoin Capsules - an antibiotic drug currently sold in the US market.
“Although certain lots of the product were determined to not be in conformity with the approved laboratory specifications, we decided to recall all the lots,” the company said in a regulatory filing.
Ranbaxy, in which Japanese drug major Daiichi Sankyo bought a 64 percent controlling stake, made a loss of Rs.574.27 crore ($16 million) for the year ended Dec 31, 2008 as against a profit of Rs.156.68 crore the year before.
The company said while the product was unlikely to produce any serious adverse health effects, there was a remote possibility that “the non-conforming product may increase the incidence of nausea and vomiting”.
The recall is being conducted in coordination with the US Food and Drug Administration and will be at a retail level, the statement said.
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Tags: adverse health effects, antibiotic drug, conformity, coordination, daiichi sankyo, food and drug, food and drug administration, nausea, nitrofurantoin, ranbaxy, retail level, stake, us food and drug administration