published Saturday, November 24th, 2012

Generic cholesterol medication recalled

ONLINE

A list of recalled lots of generic Lipitor is at http://bit.ly/TT5tlm.

The maker of a generic brand of Lipitor has issued a major recall, saying several lots of the cholesterol-lowering pills might be contaminated with tiny glass particles.

People who take atorvastatin calcium manufactured by Ranbaxy will need to switch to generic Lipitor made by another company. The recall, posted Friday on Ranbaxy's website, applies to several lots of pills in 10-, 20- or 40-mg doses but not the 80-mg dose.

Patients need to find out if they are taking pills included in the recall.

"If I was a patient, I'd contact the pharmacy and find out the maker," said Brad Standefer, pharmacist with Access Family Pharmacy on Access Road. He said he'd heard about the recall Friday but so far hadn't had any calls from anxious patients.

Elaine Maneri, vice president of pharmacy for BlueCross BlueShield of Tennessee, also recommended that patients check to see if their medicine is included in the recall before they take another dose.

And patients "really don't have to do anything as far as insurance is concerned," Maneri said. Notification of recalls is automatic for insured patients, she said. Those who pick up their prescriptions across the pharmacy counter can just drop in and swap their pills. Mail-order customers will be mailed new medications.

In either case, the pharmacist will be reimbursed by the manufacturer, so patients don't need to worry about insurance complications.

"There should be no adverse effect as far as the patient having to pay twice," she said.

Lipitor once was the best-selling drug in the world. Since its patent expired in 2011, at least a half-dozen companies have begun making generic versions.

Ranbaxy has been making the generic since late last year, The Associated Press reported.

A call to Ranbaxy's U.S. headquarters in Philadelphia was not returned Friday. A statement on the company's website said: "Ranbaxy is proactively recalling the drug product lots out of an abundance of caution. ... This recall is being conducted with the full knowledge of the U.S. FDA."

The website said Ranbaxy, India's largest drug manufacturer, makes dozens of generic products including anti-infectives, cardiovascular medicines, NSAIDs, anti-expectorants, analgesics, gastrointestinal products, central nervous system products and controlled substances.

The Food and Drug Administration has kept the company under scrutiny since manufacturing deficiencies dating to 2006 led to a lengthy investigation and sanctions, the AP reported. Federal investigators found Ranbaxy didn't properly test the shelf life and other safety factors of its drugs and then lied about the results.

In mid-2008, the FDA barred Ranbaxy from shipping into the United States more than 30 different drugs made at factories in India, the AP reported. In December 2011, Ranbaxy signed a consent decree with the FDA agreeing to improve manufacturing procedures, ensure product data and undergo five years of extra oversight and review by an independent third party. Ranbaxy at the time set aside $500 million to cover potential criminal and civil liability stemming from the U.S. Department of Justice investigation.

about Judy Walton...

Judy Walton has worked 25 years at the Chattanooga Times and the Times Free Press as an editor and reporter focusing on government coverage and investigations. At various times she has been an assistant metro editor, region reporter and editor, county government reporter, government-beat team leader, features editor and page designer. Originally from California, Walton was brought up in a military family and attended a dozen schools across the country. She earned a journalism degree ...

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