More than 40 lots of Ranbaxy Laboratory’s generic version of the cholesterol-lowering drug Lipitor are being recalled in the U.S. because small glass particles were found in the pills. Ranbaxy is one of six drug companies that make a generic version of Lipitor, however Ranbaxy’s generic Lipitor sales cover nearly half of the U.S. market.
The recall will cause a temporary supply disruption, and could lead to a shortage of atorvastatin, the generic name for Lipitor. The FDA is monitoring the situation, and is even reaching out to other manufacturers to mitigate the shortage. No injuries or deaths associated with the recall have been reported to the FDA.
The recall includes certain lots of 90- and 500-pill bottles of atorvastatin, in dosage strengths of 10 milligrams, 20 milligrams, and 40 milligrams. The 80-milligram dosage isn’t included in the recall. Pills in the selected lots may contain glass particles measuring less than one millimeter.
A list of the lot numbers and product details of all recalled generic Lipitor made by Ranbaxy are listed here: http://www.ranbaxyusa.com/images/a.pdf.
This isn’t the first time quality questions were raised about manufacturing practices at Ranbaxy. In January, the U.S. Justice Department alleged that there were flaws with the drug company’s manufacturing practices and quality controls at several of its plants. The allegations did not include practices at the plan where the generic Lipitor is produced.
The drug company was also accused of falsifying data used to gain clearance to market drugs in the U.S. Ranbaxy is now barred from producing some generic drugs in the U.S. until problems are corrected and the injunction is lifted. The ruling does not ban Ranbaxy from producing generic Lipitor.