Ranbaxy Pharmaceuticals, the largest producer of the generic version of Lipitor, has halted production of the drug until it can figure out why glass particles may have ended up in pills that were distributed to the public, the Food and Drug Administration announced Thursday.
The agency said it had not received any reports of patients being harmed by the particles, which are about the size of a grain of sand. Earlier this month, Ranbaxy recalled more than 40 lots of the drug because of the glass contamination.
The company has declined to say where the drug was manufactured or why the problem occurred, but a spokeswoman for the F.D.A. said Thursday that the company would stop making the pill’s active ingredient, which is made in India, until the investigation is completed.
The contamination was the latest episode in a history of manufacturing lapses at Ranbaxy, which is a subsidiary of the Japanese pharmaceutical company Daiichi Sankyo. The company has been operating under a court-ordered consent decree since January, one that federal authorities have called “unprecedented in scope,” after they identified a host of manufacturing problems at the company’s plants in India and the United States, and concluded that Ranbaxy had submitted false data in drug applications to the F.D.A..
The decree prevents Ranbaxy from manufacturing drugs at its most troubled facilities until it can show it is meeting United States standards, although it was allowed to continue making products — including the generic version of Lipitor — at other plants.
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This story led to a lot of questions for me, including the question of what we, as consumers, can do to protect ourselves. I had a discussion with Pfizer's media rep, who advised me to ask for the "Watson Generic" of Lipitor. This is one way that we can at least be sure that the medicine we are taking is made here in the United States, which makes it easier for the FDA to ensure its safety.
