Generic Lipitor Recall

By Daniel J. DeNoon
WebMD Health News

Reviewed by Louise Chang, MD

Nov. 26, 2012 -- 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.

SOURCES: News release, Ranbaxy Pharmaceuticals Inc. Ranbaxy web site. FDA web site. Sarah Clark-Lynn, FDA public information officer. Wall Street Journal web site, accessed Nov. 23, 2012.

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Firm Stops Making Generic Lipitor After Recall

By Daniel J. DeNoon
WebMD Health News

Reviewed by Louise Chang, MD

Nov. 30, 2012 -- After recalling 41 lots of its generic Lipitor -- atorvastatin -- the FDA says Ranbaxy Inc. will stop making the drug "until it has thoroughly investigated" how glass particles got into the medication.

Although Ranbaxy supplied more than 40% of the generic cholesterol-lowering drug sold in the U.S., the FDA says it does not expect a shortage. Five other firms make generic Lipitor: Sandoz, Teva, Apotex, Mylan, and Dr. Reddy's.

The FDA says the tiny glass particles contaminating Ranbaxy's atorvastatin have only "a remote possibility" of causing harm. Ranbaxy says the particles, about the size of a grain of sand, might cause "physical irritation."

Ranbaxy makes atorvastatin, and puts it into pill form at its U.S. facilities. The active ingredient, however, comes from India. Ranbaxy's preliminary investigation suggests that this active ingredient was contaminated with the glass particles, according to FDA public information officer Sarah Clark-Lynn.

To date, there have been no reports of harm linked to Ranbaxy generic Lipitor.

It's not the first sign of trouble for Ranbaxy, the huge Indian pharmaceutical company owned by Japan's Daiichi Sankyo. Last January, the company signed an FDA-requested consent decree closing plants in India and the U.S. until it made "fundamental changes." None of those plants made the recently recalled generic Lipitor products.

The company admitted to several serious charges, including submitting false data to the FDA, failing to prevent contamination of sterile drugs, failing to prevent penicillin contamination of non-penicillin drugs, and inadequate testing of drugs to ensure they kept their potency until their expiration date.

The U.S. Justice Department said the action was "unprecedented in its scope."

The recalled atorvastatin comes as a white tablet packaged in plastic bottles. The 10-mg tablets bear the imprint "RX12," the 20-mg tablets bear the imprint ''RX828," and the 40-mg tablets bear the imprint "RX829." No 80-mg tablets are included in the recall.

Here's the list of the recalled atorvastatin products:

ATORVASTATIN Calcium Tablets 10mg x 90ATORVASTATIN Calcium Tablets 10mg x 90ATORVASTATIN Calcium Tablets 10mg x 90ATORVASTATIN Calcium Tablets 10mg x 90ATORVASTATIN Calcium Tablets 20mg x 90ATORVASTATIN Calcium Tablets 20mg x 90ATORVASTATIN Calcium Tablets 20mg x 90ATORVASTATIN Calcium Tablets 20mg x 90ATORVASTATIN Calcium Tablets 20mg x 90ATORVASTATIN Calcium Tablets 20mg x 90ATORVASTATIN Calcium Tablets 20mg x 90ATORVASTATIN Calcium Tablets 20mg x 90ATORVASTATIN Calcium Tablets 20mg x 90ATORVASTATIN Calcium Tablets 20mg x 90ATORVASTATIN Calcium Tablets 20mg x 90ATORVASTATIN Calcium Tablets 20mg x 90ATORVASTATIN Calcium Tablets 20mg x 90ATORVASTATIN Calcium Tablets 40mg x 500ATORVASTATIN Calcium Tablets 40mg x 500ATORVASTATIN Calcium Tablets 40mg x 500ATORVASTATIN Calcium Tablets 40mg x 90ATORVASTATIN Calcium Tablets 40mg x 90ATORVASTATIN Calcium Tablets 40mg x 90ATORVASTATIN Calcium Tablets 40mg x 90ATORVASTATIN Calcium Tablets 40mg x 90ATORVASTATIN Calcium Tablets 40mg x 90ATORVASTATIN Calcium Tablets 40mg x 90ATORVASTATIN Calcium Tablets 40mg x 90ATORVASTATIN Calcium Tablets 40mg x 90ATORVASTATIN Calcium Tablets 40mg x 90ATORVASTATIN Calcium Tablets 40mg x 90ATORVASTATIN Calcium Tablets 40mg x 90ATORVASTATIN Calcium Tablets 40mg x 90ATORVASTATIN Calcium Tablets 40mg x 90ATORVASTATIN Calcium Tablets 40mg x 90ATORVASTATIN Calcium Tablets 40mg x 90ATORVASTATIN Calcium Tablets 40mg x 90ATORVASTATIN Calcium Tablets 40mg x 90ATORVASTATIN Calcium Tablets 40mg x 90ATORVASTATIN Calcium Tablets 40mg x 90ATORVASTATIN Calcium Tablets 40mg x 90SOURCES: News release, FDA. FDA web site. Department of Justice web site. Ranbaxy web site.

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