Product recall may spell trouble for Sun Pharma's US arm review

One of the products recall in the world’s largest drug market by the US arm of Sun Pharma, India’s largest drugmaker by market
capitalisation, will have minimal impact on the parent’s consolidated revenues, analysts said. But it could affect the ongoing review of the Detroit-based plant by the US drug regulator.
In October 2008, the US FDA had issued a warning to Sun Pharma’s US subsidiary, Caraco Pharmaceuticals, for “inadequate investigation by the quality control unit of certain incidents at the Detroit facility”. The US FDA is still reviewing the plant and Sun Pharma is in touch with the drug regulator to resolve the issue.
On Tuesday, Caraco Pharmaceuticals voluntarily recalled its cardiac drug Digoxin in 0.125 mg and 0.25 mg, distributed before March 31, 2009 and which expire before September 2011. “The tablets are being recalled because they may differ in size and therefore, could have more or less of the active ingredient, Digoxin,” a Caraco statement said.
Digoxin is a drug used to treat heart failure and abnormal heart rhythms. An overdose may pose a risk of Digoxin toxicity leading to nausea, vomiting, dizziness, low BP, cardiac instability, and bradycardia. Death can also result from excessive Digoxin intake. A lower dosage may potentially result in cardiac instability, Caraco added. But the drug recall is going to have little impact on the company as Digoxin has annual sales of just about $3 million (Rs 15 crore).