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30 November 2012

UPDATE on Atorvastatin (Generic Lipitor) Recall: Where did Contaminated Atorvastatin Come From?

Where Did Contaminated Atorvastatin Come From?
People's Pharmacy, 27 November 2012

By now you no doubt know that a generic formulation of Lipitor (atorvastatin) made by the Indian company Ranbaxy was contaminated with small glass particles. The company announced its recall last week and we were among the first to report on it. Here is a link to our initial story about the Ranbaxy recall of atorvastatin.

What was not available until a few days ago was information about where the problem atorvastatin was actually made. Ranbaxy has manufacturing plants in at least eight countries including India and the U.S. This Indian company is now owned in large part by a Japanese company (following the money trail gets complicated) and exports drugs to over 100 countries around the world.

We have been searching to find out where the contaminated atorvastatin originated. Was it from a New Jersey plant or from a plant in India? According to pharmaceutical industry insiders (FiercePharma) the problem plant was an Indian manufacturing facility. According to FiercePharma, "The generic Lipitor that Ranbaxy Laboratories has recalled came out of an Indian plant that the FDA let out of the doghouse only 7 months ago." That's because this same company got into trouble with other generic drugs back in 2008 (see our prior story on this mess).

What was the problem with Ranbaxy products? Well, it turns out that the company fudged on data it submitted to the FDA. There were serious quality control questions about the manufacturing and monitoring process and over two dozen different products were banned from importation into the U.S. They included the cholesterol-lowering drugs simvastatin and pravastatin.

Since the Ranbaxy affair it has been revealed that there are serious problems with the approval and testing of drugs in India. Among other serious flaws, the Indian parliament discovered that drugs were approved without clinical trials. One wonders how many Indian manufacturing plants are inspected by the FDA as required by law. This is the same concern we have about chemical companies in China. The FDA has admitted that it only inspects a small fraction of the manufacturing facilities in China, India or dozens of other countries. This means that oversight leaves much to be desired.

We are beginning to agree with many of the people who have posted on our website that more generic drugs should be made in the U.S. rather than in places where the FDA has little ability to inspect or monitor quality. We need jobs in the U.S. Why not make medicines here in plants that can be inspected on a regular basis?

In the meantime, there is likely to be a shortage of generic atorvastatin. According to Bloomberg:

"The recall by the drugmaker, based near New Delhi, may lead to a shortage of generic Lipitor in the U.S., Stephanie Yao, a spokeswoman for the Food and Drug Administration, said in an e- mail. The agency is working with other drugmakers to help fill the void in supply, she said.

"About 1 million prescriptions a week are written in the U.S. for generic copies of Lipitor, and Ranbaxy is the biggest supplier of the drug, according to data compiled by Bloomberg. Without Ranbaxy, Mylan Inc. (MYL) and Watson Pharmaceuticals Inc. (WPI) may be able to pick up a larger share of the market, said Bloomberg Industries analyst Asthika Goonewardene."


There is tremendous confusion in the marketplace about what to do with your Ranbaxy atorvastatin. Let's be perfectly clear. There IS a recall of 10-, 20- and 40 milligram pills from this company [see this link for the affected lot numbers]. That said, neither the FDA nor Ranbaxy have been forthcoming about whether there is a danger to patients. Because there is ambiguity, pharmacies may elect not to issue credit and dispense new non-Ranbaxy atorvastatin. We have heard from patients that when they requested either a generic atorvastatin from a different manufacturer or the brand name Lipitor, they were refused and told to just keep taking their Ranbaxy atorvastatin. We think that is crazy. If it has been determined that the identified lots have glass particles and should be returned to the manufacturer, then why should patients keep swallowing pills from these recalled lots? It is estimated that 3 to 4 millions Americans are taking Ranbaxy atorvastatin.

Here is our recommendation:

If you are taking atorvastatin (10-, 20- and 40-milligram pills), contact your pharmacist to find out whether it came from Ranbaxy and whether your pills are part of the recalled lots. Tell your pharmacist you will bring or send (in the case of mail-order pharmacies) the pills back in return for either Lipitor or non-recalled generic atorvastatin. Do NOT accept no for an answer. Your insurance company should make good and not require another co-pay for the substituted atorvastatin.

In the event of shortages of generic atorvastatin (a distinct possibility), you may need to ask for Lipitor or another statin-type drug to cover you during this period when Ranbaxy will be out of the game with its most popular atorvastatin dosage forms.

The sad reality of this recall is that once again confidence in generic drugs has been shaken. The FDA's ability to monitor generic drug manufacturing and quality is under question. Of course there have also been problems with brand name companies over the last few years. Johnson & Johnson got into trouble with products such as Motrin, Zyrtec, Tylenol and Benadryl at its plant in Fort Washington, PA.

If the FDA has trouble ensuring the quality of a major brand like Tylenol made in the U.S., it's hardly any wonder it has challenges in China and India where most of today's generic drugs are manufactured.


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