(WASHINGTON) — The pharmaceutical company that makes the generic version of the cholesterol-lowering drug Lipitor, also known as atorvastain, has shut down production while it tries to figure out how tiny glass particles got into the pills, the Food and Drug Administration announced on Thursday.
The federal agency said it had not received any reports of patients being harmed by the glass particles found in pills manufactured by Ranbaxy Pharmaceuticals.
Earlier this month, the company, which is the largest producer of the generic version of Lipitor, recalled more than 40 lots of the drug because of the glass contamination.
The company has not said where the generic drug was manufactured or how the problem occurred, but a spokesperson for the FDA said Ranbaxy has agreed to stop making the pill’s active ingredient until an investigation is complete. The active ingredient is made in India.
The incident is the latest episode in a recent history of manufacturing lapses at the company. Earlier this year, Ranbaxy was barred from importing 30 drugs after federal authorities discovered the company had numerous record-keeping violations and manufacturing problems at overseas facilities.
Dr. Edward Boyer at the University of Massachusetts Medical School said the contamination is not necessarily a threat to a person’s health, but it is a cause for concern.
He says eating a pill that has particles of glass a millimeter in size or less is akin to swallowing a pill containing small bits of sand. Still, Dr. Boyer said if a patient on the medicine came to him, he would recommend they replace it with a known, safe alternative.
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