Glenmark Pharmaceuticals recalls stomach ulcer drug ranitidine in US

Apr 18 2014, 18:41 IST
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Medicines produced in India, which supplies about 40% of generic and over-the-counter drugs sold in the US, have come under increased scrutiny by the FDA. Medicines produced in India, which supplies about 40% of generic and over-the-counter drugs sold in the US, have come under increased scrutiny by the FDA.
SummaryGlenmark Pharmaceuticals is recalling some 2,900 bottles of its stomach ulcer drug ranitidine in the United States after a foreign tablet was found in one of the bottles.

Glenmark Pharmaceuticals Ltd is recalling some 2,900 bottles of its stomach ulcer drug ranitidine in the United States after a foreign tablet was found in one of the bottles.

Medicines produced in India, which supplies about 40 percent of generic and over-the-counter drugs sold in the United States, have come under increased scrutiny by the Food and Drug Administration over the past year.

In the last six months alone, products made by some of India's largest drugmakers, including Ranbaxy Laboratories Ltd, Sun Sun Pharmaceuticals Industries and Dr Reddy's Laboratories have been recalled from the United States.

The lot being recalled was manufactured for Glenmark Pharmaceuticals by another Indian drugmaker Shasun Pharmaceuticals Ltd, and the foreign tablet was identified to be metoprolol tartrate, a drug to treat high blood pressure, according to information posted by the FDA on Thursday. The recall began on March 18.

"Corrective actions have been implemented and the recall is limited to only one lot of material," a Glenmark Pharmaceuticals representative said in a statement to Reuters. "Financially, the impact of the recall is very insignificant."

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