The Daily Southerner, Tarboro, NC

Local News

November 29, 2012

Recall of generic Lipitor has potentially broad reach

TARBORO — If you are one of the many Americans with a cholesterol problem, the odds are that your physician has written you a prescription for atorvastatin — better known by the trade name Lipitor. In fact, until Nov. 30, 2011 when Pfizer's patent expired, there was only Lipitor.

Now, six firms are licensed by the Food and Drug Administration (FDA) to produce atorvastatin and the largest, India's Ranbaxy Pharmaceuticals, holds 44 percent of the market share with between 3 million and 4 million customers.

Last Friday, amid the wind down from Thanksgiving and the build-up of Black Friday, Ranbaxy quietly issued a recall for an undisclosed number of the calcium tablets.

The news slipped quietly under the public radar until this week and now, the company, which has a history of problems with the FDA, is facing increasing criticism over its recall, which reads:

"Ranbaxy Pharmaceuticals Inc. is conducting a voluntary recall for Atorvastatin calcium tablets, in connection with its 10mg, 20mg and 40mg dosage strengths, packaged in 90’s and 500 count bottles and only with respect to certain select lot numbers. The recall does not affect or relate to the 80mg strength. The recall is being conducted at the retail level for such select batches that may contain a foreign substance (small glass particles approximately less than 1mm in size). Ranbaxy is proactively recalling the drug product lots out of an abundance of caution, and in keeping the safety of our customers in mind. This recall is being conducted with the full knowledge of the U.S. FDA."

Ranbaxy does not disclose how many doses may be affected and refers visitors to its website to a list of batch numbers to see if they may be taking glass-tainted cholesterol medication.

And despite the recall, millions of people may continue taking

glass-contaminated medication. Ranbaxy's retail recall directed pharmacies not to dispense contaminated lots of the drug, but gave no directions to patients who have the drug at home.

"Patients are sandwiched between two groups who are being less than helpful: the FDA and Ranbaxy," said Lisa Gill, editor of prescription drugs at Consumer Reports.

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