The Federal Drug Administration announced on Wednesday that it was revising its recommendations on generic Lipitor produced by Ranbaxy. The FDA now says the drug is safe to take.
"FDA is notifying the public that after reviewing additional information related to the Ranbaxy atorvastatin recall, FDA has determined that the possibility of adverse health problems related to the recalled atorvastatin is extremely low," said the FDA in a statement.
The pharmaceutical company that makes the generic version of the cholesterol drug Lipitor agreed to halt production and recall supplies after glass shards were found in the pills.
The FDA said India-based Ranbaxy Pharmaceuticals agreed to stop producing the drug atorvastatin, when it couldn't explain how the glass found its way into the pills.
"I think the quick message is that the company has real difficulties with quality control," said Dr. Edward Boyer of the University of Massachusetts Medical School.
The company first issued a recall on Nov. 9, but had been unable to determine the source of the problem. Since then, there are unverified reports that a piece of glass from mixing equipment in an Indian factory was introduced into the product.
The tiny glass particles are unlikely to pose a danger to human life. At a millimeter in diameter or smaller, they are about as irritating as sand, but they could cause irritation of the digestive system.
"Consumers who are concerned that they may have received a recalled product should consult with their pharmacist where they bought the product to confirm whether they received a recalled product, should stop taking the product if it was recalled, and should consult with their pharmacist or physician about how to obtain an alternative product," the FDA said in a statement.
Ranbaxy makes about a third of the supply of generic Lipitor in the country. The FDA doesn't expect a shortage of the drug, since there are many other suppliers.
Brand-name Lipitor was once the best-selling drug in the world until the patent expired. Now most insurance companies only cover generic versions, which cost about $1 per pill less.