Sun Pharma subsidiary Caraco asked to withdraw metformin pills in US

Caraco Pharmaceutical Laboratories, the US subsidiary of Mumbai-based Sun Pharmaceuticals Industries, has been asked to withdraw many batches of its generic metformin hydrochloride tablets used for treating diabetes.

The US FDA has asked the withdrawal of the metformin tablets due to concerns on efficacy and quality of the pill.

Moreover, the metformin pills produced by Caraco Pharma was also mis-shaped – undersized and oversized tablets, which could result in patients not receiving the expected dose, the USFDA deemed.

The withdrawal was necessitated by undersized and oversized tablets, which could result in patients not receiving the expected dose, said the regulator.

Caraco will have to withdraw seven lots of Metformin Hydrochloride in bottles of 100, 500 and 1000 tablets each, according to a USFDA Class II withdrawal announced on March 19.

Caraco has voluntarily initiated the recall. The recall was valid nationwide and 22,156 bottles of the drug were in circulation in the US, said US FDA.

Metformin Hydrochloride, is a generic version of Bristol Myers Squibb’s Glucophage. Caraco launched the drug in the US in February 2002.

Caraco, which is listed in US stock exchange, had sales of $117 million in FY07 and markets over 40 products in the US market.

In April, Sun Pharma received US regulatory approval to market Roxicodone, Oxycodone hydrochloride tablets used as painkillers.

The tablets are in the strength of 5mg, 15mg and 30mg and is used as a narcotic painkiller in the treatment of moderate to severe pain.

Before that in January Sun Pharma announced that it received approval from the US FDA for several Abbreviated New Drug Applications (ANDA) for its generic products, including hydocodone bitartate with acetaminophen (APAP) tablets, aredia, lopid and phenargan.

In November 2007, the FDA asked Ranbaxy to withdraw its Gabapentine tablets for excessive impurity specification.

The FDA had also suspended production at the manufacturing facilities of Leineur Health Systems, Dr Reddy’s Laboratories US partner for over the counter drugs, citing quality issues. Subsequently, Dr Reddy’s severed the tie-up with Leineur Health and launched its own products in the US market.

Established in 1983 and  listed since 1994, Sun Pharmaceutical Industries Ltd is an international, integrated, speciality pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world. In India, the company is a leader in niche therapy areas of psychiatry, neurology, cardiology, diabetology, gastroenterology, and orthopedics. The company has strong skills in product development, process chemistry, and manufacturing of complex API, as well as dosage forms.