Ranbaxy Falls After Second Recall of Generic Lipitor in U.S.
The Indian drugmaker’s shares fell as much as 3.9 percent to 356 rupees, headed for the biggest decline since Jan. 27, before trading at 357 rupees at 9:37 a.m. local time. The benchmark S&P BSE Sensex gained 0.2 percent.
The company, a unit of Tokyo-based Daiichi Sankyo Co. (4568), is withdrawing pills in 64,626 bottles of atorvastatin calcium from the U.S. market after a product complaint was received by a pharmacist, the U.S. Food and Drug Administration said on its website. It is the second recall of Ranbaxy’s generic cholesterol lowering medicine in 15 months.
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.
The voluntary recall, announced last week on the FDA website, was initiated when a U.S. pharmacist discovered a 20 milligram tablet in a sealed bottle marked for 10 milligram pills.
Ranbaxy has not 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 statement said.
FDA officials have said they plan to tighten rules on how they regulate the generic drug industry as a way to persuade 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.
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