Ranbaxy recalls two consignments of drugs from US market
15 Apr 2010
Ranbaxy Laboratories has voluntarily recalled two consignments of one of its antibiotics amoxicillin and clavulanate potassium from the US market.
Analysts say the move is not likely to impact its revenues but can be expected to affect its ongoing problems with the US drug regulator.
The drugmaker said the reason for the recall from the US market is due to its oral suspension turning brown during reconstitution, instead of white.
According to a company spokesman, the recall was being carried out at the retail level and conducted with the USFDA's full knowledge. The US retail market has about 35,000 bottles of the drug which expires in May this year.
The company is majority owned by Japanese drug maker Daiichi Sankyo.
Complaints were reported with some drugs in two batches but the company said its tests showed that though the drugs conformed to specification, it nevertheless decided to recall all lots on considerations of abundant precaution, according to the spokesperson.
The US Food and Drugs Administration (FDA) has already banned around 30 drugs the company makes at its two plants in India for US manufacturing norms violations.
Over the last one year the company has also had to voluntarily recall a few other products in the US.
The latest recall pertains to the company's product from its Dewas plant and is being recalled by the company's US arm Ranbaxy Pharmaceuticals. The recall falls under class II category which means the use of the product would likely not case any serious health problem.