India's biggest drugmaker Ranbaxy announced Saturday the recall of an antibiotic, on sale in the United States, because of manufacturing problems, marking a new setback for the company.
The Japanese-owned company said it was voluntarily recalling all lots of Nitrofurantoin capsules, an antibiotic commonly used in the treatment of urinary tract infections, and being sold in the United States.
"Certain lots of the products were determined to not be in conformity with the approved laboratory specifications," a company statement said, giving no further details about the problems.
"To the best of Ranbaxy's knowledge, the recalled product is unlikely to produce any serious adverse health effects," the company said.
But Ranbaxy Laboratories Ltd added there was "a remote possibility that the non-conforming product may increase the incidence" of nausea and vomiting.
Ranbaxy said it was carrying out the recall of the 100 milligram capsules in coordination with the US Food and Drug Administration (FDA) and had decided to recall all lots of the drug "as a matter of abundant caution."
Ranbaxy gave no details about the financial effects of the recall, which was the latest bad news for the firm in which Japanese pharmaceutical company Daiichi Sankyo last year bought a controlling 64 percent stake for 4.6 billion dollars.
Tokyo-based Daiichi Sankyo has seen the value of its investment sink as a result of a flurry of bad regulatory news.
Last month, Ranbaxy, the country's biggest drugmaker by revenues, reported it had swung to a first-quarter loss of 7.61 billion rupees (153 million dollars) from a profit of 858 million rupees in the same period a year earlier.
The loss was driven by a US import ban and wrong-way bets on the movement of the Indian rupee.
The FDA last September banned imports of more than 30 generic drugs produced by Ranbaxy including antibiotics and AIDS drugs because of problems in their manufacture at two of the company's Indian plants.
In February, the FDA said Ranbaxy falsified data and test results "in approved and pending drug applications."
Ranbaxy has said it is working with the FDA to resolve the sales ban in the United States, the world's largest drug market.