Ranbaxy forced to recall drug from US mkt

Withdrawal of nitrofurantoin capsules in coordination with the US FDA and will be at retail level.

Ranbaxy Laboratories is facing more trouble in the US. Quality issues have forced the company to withdraw all batches of a generic urinary infection antibiotic drug.

Ranbaxy Pharmaceuticals Inc (RPI), the US subsidiary of Ranbaxy, today said it was conducting a voluntary recall of all lots of nitrofurantoin (monohydrate/macrocrystals) 100 mg capsules currently in the market in the US.

“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”, the company said in a statement.

Sources said nitrofurantoin was an old molecule and competition in the generic market was severe in the US market. The recall was unlikely to affect Ranbaxy much as it was not selling the drug in large quantities in the US, they said.

A company spokesperson declined to reveal the sales figure for the drug in the US market.

Last year, the US drug regulator, the Food and Drug Administration(FDA), had banned 30 drugs made by Ranbaxy at its Poanta Sahib and Dewas plants. The FDA had alleged that Ranbaxy doctored data and test results of some the drugs manufactured at these plants. Investigations are on and the FDA will not approve pending and new marketing applications from the two plants till the issue is sorted out.

The ban caused Ranbaxy’s revenue in the US to fall 31 per cent in the March quarter. Ranbaxy, India’s largest drug maker, posted a consolidated loss of Rs 761 crore in its fiscal’s first quarter ended March, mainly due to derivative losses to the tune of Rs 919 crore.

Sun Pharma’s US subsidiary, Caraco Pharmaceuticals, had to recall its cardiac drug, Digoxin, in 0.125 mg and 0.25 mg from the US market in March this year, also due to quality issues.

On nitrofurantoin, Ranbaxy said the company is continuing to look into the cause of nonconformity.

The recall is being conducted in coordination with the FDA and will be a retail level recall. The company warned that though the recalled product is unlikely to produce any serious adverse health effects, there is a remote possibility that the nonconforming product may increase the incidence of side effects such as nausea and vomiting.