The Indian drug maker Ranbaxy Pharmaceuticals announced Friday that it has started making a generic version of Lipitor again, saying that it was fixing the problems that led it to halt production of the anti-cholesterol drug after glass particles were discovered in pills.
Ranbaxy recalled more than 40 lots of the drug in November because of the glass particles, which were about the size of a grain of sand. The problem was later traced to a cracked glass lining in a mixing tank at one of the company's plants in India.
In a statement, the company said it had been working with the Food and Drug Administration and "implemented multiple corrective and preventative actions" related to the contamination problem. It said it was confident in the safety of its drugs.
The recalls involved the 10-, 20- and 40-milligram doses of the drug, and did not affect drugs sold outside of the United States.
F.D.A. officials said in November that the chances of harm to patients were "extremely low," and the recall applied only to pharmacies, which were instructed to return the affected pills. Consumers who already had the contaminated pills were advised to continue taking them unless a doctor advised against it.
Since then, some consumers have sued Ranbaxy, claiming they suffered loose stools, stomach discomfort and other problems after ingesting the drug. One patient claimed it caused internal bleeding and holes in her stomach. Ranbaxy has said the complaints are not credible and, apart from the woman who suffered internal bleeding, said the problems were similar to common side effects of the drug.
A spokeswoman for the F.D.A. said it has not received any reports of adverse events related to the glass particles in the pills.
The recall was the latest episode in a series of manufacturing problems at the company, which is a subsidiary of the Japanese pharmaceutical company Daiichi Sankyo. Since early last year, Ranbaxy has been operating under a court-ordered consent decree after federal authorities identified a string of manufacturing lapses at company plants in the United States and India and said that Ranbaxy submitted falsified data in drug applications to the F.D.A.
Ranbaxy was one of the first companies to sell the generic Lipitor, also known as atorvastatin, after Pfizer lost patent protection for its top-selling drug in November of 2011. As of last October, Ranbaxy held more than 40 percent of the United States market.
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