Ranbaxy Laboratories Ltd, India’s largest drug manufacturer by sales, announced a voluntary recall of its generic version of the cholesterol-lowering drug Lipitor from the U.S. market.
Ranbaxy’s U.S. division, Ranbaxy Pharmaceuticals Inc., has recalled various batches of its Atorvastatin calcium tablets -- a generic version of the Lipitor drug -- from the market, the company said in a statement.
“Ranbaxy Pharmaceuticals Inc. is conducting a voluntary recall for Atorvastatin calcium tablets, in connection with its 10mg, 20mg, and 40mg dosage strengths, packaged in 90- and 500-count bottles, and only with respect to certain select lot numbers. The recall does not affect or relate to the 80mg strength,” the company said in a statement on its website.
Ranbaxy was the first company to launch a generic version of Lipitor after Pfizer Inc.'s (NYSE: PFE) patent expired in November 2011. The drug was responsible for generating $600 million in sales for the company.
Ranbaxy has had compliance issues with the U.S. Food and Drug Administration (FDA) in the past. The FDA banned shipments from some of Ranbaxy’s manufacturing units in 2009, when the company agreed to take corrective steps in its plants, Reuters reported.
However, industry experts have said that the current recall indicates that such corrective measures are not adequate and that the recall will affect the company’s revenues.
"The development will impact the company's credibility to an extent," said Bhagwan Singh Chaudhary, a research associate at the brokerage IndiaNivesh.
"There have been issues in the past [about compliance], and a recall suggests [that the] corrective measures suggested by the US FDA are not being implemented," he said, according to Reuters.
However, Ranbaxy said the recall was being done voluntarily to keep customers’ safety in mind, and the FDA has full knowledge of the issue.
“The recall is being conducted at the retail level for such select batches that may contain a foreign substance (small glass particles approximately less than 1mm in size). Ranbaxy is proactively recalling the drug product lots out of an abundance of caution, and in keeping the safety of our customers in mind. This recall is being conducted with the full knowledge of the U.S. FDA,” the company said.
Click here for the complete list of the batches of drug being recalled.