Reeling under a flurry of regulatory rebukes due to quality control, Ranbaxy Laboratories, has recalled around 64,000 bottles of the generic version of a cholesterol-lowering drug in the US after dosage mix-up was reported to the US health regulator.
Ranbaxy, India’s biggest drug maker by revenue and the majority owned by Japan’s Daiichi Sankyo, voluntarily recalled 64,626 bottles containing atorvastatin calcium (generic version of Lipitor) tablets after a US-based pharmacist found a 20-milligram tablet in a sealed bottle marked for 10-milligram tablets, said the enforcement report by the US Food and Drug Administration.
The recall happened in January, the report said. The FDA classified the recall as Class II, which signifies a remote chance of severe adverse consequences or death due to the product flaw.
Ranbaxy confirmed the recall. “We are conducting a voluntary recall in the US,” said the spokesperson. “To date, Ranbaxy has not received any product complaints related to these batches. Other lot numbers, package sizes and strengths are not affected by this.”