Bloomberg News

Sun Pharma, Ranbaxy Recall Some Generic Drug Batches in U.S.

March 10, 2014

Indian generic-drug makers Sun Pharmaceutical Industries Ltd. (SUNP) and Ranbaxy Laboratories Ltd. (RBXY) recalled some batches of drugs in the U.S. after separate complaints of bottling mix-ups.

Sun Pharma is recalling a batch of generic diabetes tablets after a customer complained of finding pills of an epilepsy medication mixed in. Separately, rival Ranbaxy pulled two batches of its version of Pfizer Inc. (PFE:US)’s Lipitor cholesterol-lowering drug from the U.S. market. Both recalls were listed in the Food and Drug Administration’s enforcement report for the week of March 5.

FDA officials have said they plan to tighten rules on how they regulate the generic-drug industry as a way to convince American consumers that safeguards are in place. Generic drugs, which make up almost 80 percent of the medicine used in the U.S., helped Americans save $193 billion in 2011 as health-care costs rise and insurers force more consumers to use them.

Sun initiated a voluntary recall of 2,528 bottles of metformin hydrochloride extended release tablets after a customer complained of the presence of some gabapentin tablets, a drug used to treat seizures, in a bottle, according to a posting on the FDA website. The batch was manufactured in April 2013 and was set to expire in March 2016.

Sun Pharma is “examining the issue, and would not have anything specific to share beyond the announcement that the U.S. FDA has made,” the company said in a statement.

Sun’s recall of the batch of metformin hydrochloride was initiated on Jan. 28, according to the FDA posting.

Generic Lipitor

Ranbaxy recalled 64,626 bottles of its copies of Lipitor after a pharmacist complained of a 20-milligram pill in a sealed 10-milligram bottle, according to an FDA website posting. The recall, its second of atorvastatin in the last 15 months, was initiated on Jan. 16.

Ranbaxy is facing greater U.S. scrutiny after recalling generic Lipitor in November 2012 for possibly containing small particles of glass. Four of Ranbaxy’s Indian facilities have been banned from exporting to the U.S. for failing to meet FDA standards. The company declined to say whether the latest batches to be recalled were made in its plant in New Brunswick, New Jersey.

Ranbaxy hasn’t received any product complaints related to the recalled batches, the company said in an e-mailed statement on March 8. The recall has been conducted at the retail level, the company said.

“Ranbaxy is proactively recalling the lots out of an abundance of caution, keeping the safety of its patients in mind and with the full knowledge of the U.S. FDA,” the company said.

Ranbaxy fell 1.6 percent to 364.60 rupees at the close of Mumbai trading, its biggest decline since Feb. 21. Sun Pharma fell 2.5 percent.

To contact the reporter on this story: Ketaki Gokhale in Mumbai at kgokhale@bloomberg.net

To contact the editors responsible for this story: Anjali Cordeiro at acordeiro2@bloomberg.net Kristen Hallam


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