Tuesday, December 4, 2012
India - Ranbaxy Halts Generic Lipitor Production After Glass Contamination Scare
A possible contamination with very small glass particles has sparked the voluntary recall of Ranbaxy Pharmaceutical’s atorvastatin tablets.
A possible contamination with very small glass particles similar to the size of a grain of sand has sparked the voluntary recall of Ranbaxy Pharmaceutical’s atorvastatin tablet, the generic version of Pfizer Inc.’s Lipitor.
Lipitor, the best-selling drug in the history of the pharmaceutical industry, is a cholesterol-lowering medicine in a class of drugs called statins that lower LDL or bad cholesterol.
On November 9, Ranbaxy Pharmaceuticals informed its customers of a voluntary recall of certain lots of the company’s 10 mg, 20 mg, and 40 mg dosage strengths of atorvastatin tablets, packaged in bottles of 90 and 500 tablets, for a possible contamination with very small glass particles.
The recall does not include atorvastatin 80 mg strength or other Ranbaxy products.
The generics manufacturer says it has stopped making atorvastatin until it has thoroughly investigated the cause of the contamination and remedied the problem.
At the time of this report, the U.S. Food and Drug Administration (FDA) says it has not received any reports of patient injury due to glass particulates that may be in the recalled product.
After further review, the FDA adds that the possibility of adverse health problems related to the recalled atorvastatin is extremely low.
“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,” says an advisory on the FDA website.
The FDA says it does not anticipate a drug shortage of the cholesterol-lowering drug, and is working with other manufacturers to ensure adequate market supply during the ongoing recall.
Ranbaxy Inc. is a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), India’s largest pharmaceutical company.