Glenmark Pharmaceuticals Ltd. (BOM:532296) is voluntarily recalling close to 3,000 bottles of its stomach ulcer drug ranitidine in the U.S. after a pharmacist complained about finding a foreign substance in one of the bottles, the U.S. Food and Drug Administration said Thursday.
The lot of recalled 150 milligram bottles were produced for the Mumbai-based company by Shasun Pharmaceuticals, which is based in Chennai. The U.S. FDA said that the foreign tablet has been identified as metoprolol tartrate, a drug to treat high blood pressure. The recall began March 18.
India accounts for more than 40 percent of generic and over-the-counter drugs sold in the U.S., and medicines made there have come under increasing scrutiny over the past year by the FDA for failing to meet its quality standards.
"We have voluntarily recalled 2,904 bottles of Ranitidine Tablets, 150 mg from one lot of material," a Glenmark representative told The Economic Times of India newspaper. "The product was manufactured at our partner's manufacturing site. Corrective actions have been implemented and the recall is limited to only one lot of material."
In a statement to Reuters, the Glenmark representative said that "financially, the impact of the recall is very insignificant."
Several Indian companies over the past six months have issued drug recalls. Ranbaxy Laboratories (BOM:500359), India's biggest drug maker by revenue, has been banned from the U.S. drug market after falling short of the FDA’s “good manufacturing practices.” In March, Ranbaxy was forced to recall 64,626 bottles of its generic version of Pfizer's cholesterol-lowering medication Lipitor after a pharmacist complained of a 20-milligram pill in a sealed 10-milligram bottle. The company, which was acquired earlier this year by India's Sun Pharmaceutical Industries Ltd. (BOM:524715), has paid the FDA close to $500 million in fines.
Following Ranbaxy's drug recall, Sun also had to take back 2,528 bottles of its generic version of Depomed Inc.'s diabetes drug Glumetza marketed in the U.S. after the tablets got mixed in with a drug used to treat epilepsy. Depomed is a specialty pharmaceutical company based in Newark, Calif.