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Last updated on April 17, 2014 at 17:30 EDT

Drugmaker Recalls Antibiotic In The US

May 3, 2009

Due to manufacturing problems, India’s largest drugmaker announced Saturday the recall of an antibiotic currently being sold in the United States.  The company has witnessed a huge setback as a result of the recall, the Associated Free Press accounted.

The antibiotic capsules called nitrofurantoin, which is commonly used to treat urinary tract infections, was voluntarily recalled by the Japanese-operated company. 

The company did not disclose any specific information about the problems, but simply offered a statement stating that “Certain lots of the products were determined to not be in conformity with the approved laboratory specifications.”

“To the best of Ranbaxy’s knowledge, the recalled product is unlikely to produce any serious adverse health effects,” the company informed. 

However, Ranbaxy Laboratories Ltd did suggest that there was “a remote possibility that the non-conforming product may increase the incidence of nausea and vomiting.” 

Ranbaxy did not disclose any information regarding the financial repercussions of the recall, the most recent hit of misfortune for the company. 

Last year, Japanese drug company Daiichi Sankyo bought a controlling 64 percent stake for 4.6 billion dollars. 

By purchasing such a large percentage of India’s largest generic drugmaker, according to sales, Daiichi Sankyo had hoped to earn additional revenue from the copy-cat drug market after its own patents expired.

However, because of the recent negative publicity circulating in the United States, the world’s largest drug market, the company has witnessed a significant drop in the value of its investment.

Currently, Ranbaxy shares are trading at around 134 rupees ““ less than a quarter of their 52-week high of 613.70 rupees as seen last June. 

Reports last month showed that Ranbaxy dropped to a first-quarter consolidated loss of 7.61 billion rupees (153 million dollars) from a profit of 858 million rupees in the same time frame a year prior. 

Last September, the US Food and Drug Administration (FDA) prohibited imports of more than 30 generic drugs produced by Ranbaxy including antibiotics and AIDS drugs because of issues in their manufacture at the two different plants in India. 

The FDA said in February that Ranbaxy reported inaccurate data and test results in approved and pending drug applications. 

In coordination with FDA recommendations, Ranbaxy has said it was already moving forward with the recall of all lots of the 100 milligram capsules of nitrofurantoin “as a matter of abundant caution.”

The company has been permitted to sell nitrofurantoin in the US since 2005, and in that time, this is only the second instance of recall in the US market. 

The other occurrence was in 2007 when the company decided to recall 73 million tablets of gabapentin, which is used to treat epilepsy, after impurities in the drug surpassed permissible allowances. 

A potential loss of over 3.5 billion dollars is expected due to the slide in the value of the Ranbaxy investment, Daiichi Sankyo said in January. 

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