Sun recalls cholesterol drugs from US market

NEW DELHI: Sun Pharmaceuticals is voluntarily recalling about 27,000 bottles of anti-cholesterol medicine Gemfibrozil tablets from the US market after impurity levels exceeded permissible limits. New Jersey-based Sun Pharmaceutical Industries Inc, a wholly-owned subsidiary of India’s most valuable drugmaker Sun Pharma is recalling 12,036 bottles containing 500 tablets and 14,670 bottles containing 60 tablets of Gemfibrozil, as per the US drug regulator USFDA website.

Sun Pharmaceuticals declined comment on the development. USFDA said it is a Class II level recall, meaning patients who had used Sun’s products are unlikely to have any serious adverse effects. Most of the medicines expires mid-2011.

Product recalls are quite common in the US and many companies including the big innovators company have had to pull back products from the market. Analysts say the recall will not have any significant financial impact since the product is not high revenue drug and the quantum of recall is less.

“But such recalls are not good for a company that is trying hard to resolve regulatory issues with the American drug regulator. FDA may view this seriously,” Ranjit Kapadia VP Institutional Sales at HDFC Securities said. US-based Caraco Pharma, in which Sun owns a majority stake has received warning letter from the FDA for not addressing manufacturing irregularities at its Michigan facilities. FDA also seized its products and halted distribution.