Ranbaxy recalls 2 batches of antibiotics from US
 Ranbaxy laboratories is voluntarily recalling two consignments of one of its antibiotics from the US market, a move that may not impact its revenues but will affect its ongoing problems with the drug regulator, analysts said. 

The drugmaker is recalling the antibiotic Amoxicillin & Clavulanate Potassium from the US market because its oral suspension turns brown during reconstitution, instead of white. 

“The recall is being carried out at the retail level and conducted with the full knowledge of the USFDA,” a company spokesman said. A total of about 35,000 bottles are in the US retail market and the drug expires in May this year. 

Ranbaxy’s share price at the Bombay Stock Exchange (BSE) closed at Rs 460.05, down 0.70%. Ranbaxy is majority owned by Japan’s Daiichi Sankyo. 

There were complaints with some of the drugs in two batches but Ranbaxy said its tests showed the drugs to be within specification. The company decided to recall all the lots in question for precautionary reasons, he said. 

Hemant Bakhru, an analyst with brokerage firm CLSA, said such recalls will negatively impact Ranbaxy’s ongoing process to settle its problems in the US. “Financially, there should not be much impact,” he said. 

The US Food and Drugs Administration (FDA) has already banned the company’s 30 drugs, made at its two Indian plants, for violating the US manufacturing norms. In the last one year, Ranbaxy has had a few other voluntary recalls of its products in the US. 

The latest product to be affected (400mg/ 57mg (base) per 5mL) is made at the company’s Dewas plant in India and is being recalled by Ranbaxy’s US arm, Ranbaxy Pharmaceuticals. The recall is a class II category, which means the use of the product is unlikely to cause any serious health problems.

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