Caraco Pharmaceuticals, the US-based subsidiary of Sun Pharma, has come under USFDA scanner, prompting it to voluntarily recall from the US market all tablets of cardiac brand Digoxin due to safety issues. The tablets are being recalled because they may differ in size and therefore, could have more or less of the active ingredient, digoxin, the US FDA said on Wednesday. Digoxin has an annual sales turnover of $2.9 million. Sun Pharma holds 76% stake in Caraco. The company has withdrawn USP 0.125 mg and USP 0.25 mg dosages of digoxin distributed prior to March 31, 2009, which have not expired and are within the expiry date of September 2011. For the year 2008-09, the US operations of Sun Pharma, which is the second largest part of its business, had accounted for 41% of the company?s turnover. Caraco had reported revenues of $350 million, up by 200% in 2008-09.
A Sun Pharma spokesperson told FE , ?Caraco has not given any specifics of the implication and hence it is difficult for us to give specifics. But the customary implications are loss of sales and cost of recall. Caraco will continue to manufacture and sell the product.? It was in 2003 that Caraco received the US FDA approval to manufacture and market digoxin, a generic form of Glaxo Wellcome?s Lanoxin. The existence of higher than labelled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake, the US FDA statement said.
