Ranbaxy Pharmaceuticals Inc. has halted production of generic cholesterol drug Lipitor while it investigates how tiny glass particles got into dozens of batches of the drug that were recalled in November.
The Food and Drug Administration said Ranbaxy won’t resume manufacturing generic Lipitor, or atorvastatin, until it determines the problem’s cause and fixes it.
The drugmaker, a subsidiary of India’s Ranbaxy Laboratories Ltd., since last December has been operating under increased FDA scrutiny because of quality lapses at multiple factories over several years.
The recall covered 41 batches of 10-, 20- and 40-milligram doses of atorvastatin tablets.
A Ranbaxy spokesman did not immediately respond to messages Friday from The Associated Press.
Several other companies also make generic versions of Lipitor, which was the world’s top-selling drug for years.
Ranbaxy notified pharmacies and other customers about the recall on Nov. 9 but didn’t publicly disclose it until Nov. 23. It covers lots, or batches, of atorvastatin in bottles containing 90 or 500 tablets. The recall was due to “possible contamination with very small glass particles similar to the size of a grain of sand,” according to the FDA.
The regulatory agency said it has not received any reports of patients being harmed by the recalled product.