Ranbaxy Pharmaceuticals Inc., a major maker of generic Lipitor, has issued a massive recall of the cholesterol-cutting tablets, which may be contaminated with tiny glass shards.
The recall covers 41 lots of atorvastatin, the generic version of Lipitor. Each lot contains thousands of pills.
The recall includes 10 mg, 20 mg, and 40 mg dosages. It does not include 80 mg atorvastatin tablets.
No injuries have been reported from the “small glass particles approximately less than 1 millimeter in size.”
Ranbaxy says it is “proactively recalling the drug product lots out of an abundance of caution, and in keeping the safety of our customers in mind.”
Ranbaxy, an Indian firm, is owned by Japan’s Daiichi Sankyo Co. According to The Wall Street Journal, Ranbaxy’s generic Lipitor makes up 44% of the U.S. market for atorvastatin, including generic and name-brand products.
Earlier this year, Ranbaxy entered into a consent decree with the U.S. Justice Department preventing the company from selling various generic drugs on the U.S. market until it addresses manufacturing and quality-control flaws at several plants. Those plants did not make the generic Lipitor now being recalled.
The FDA is working with other atorvastatin makers to prevent a shortage of the popular cholesterol-lowering pills.
“The FDA is currently working with the other manufacturers to address any potential shortage as a result of the ongoing recall. We are monitoring the situation,” FDA spokeswoman Sarah Clark-Lynn says in an email.
A list of the recalled products, including lot and NDC numbers, is posted on the Ranbaxy web site.
By Daniel J. DeNoon
WebMD Health News