Lipitor has been the most successful drug in the history of the pharmaceutical industry. Nothing else even gets close. Sales of Lipitor exceeded more than $130 billion. In its heyday millions of people took this brand name medication and insurance companies paid top dollar for a drug doctors loved to prescribe to control cholesterol. It should come as no surprise that HMOs, insurance companies and many patients were thrilled to learn that Lipitor lost its patent last November and would become available as generic atorvastatin at a reduced price.
The first manufacturer to market a generic version of Lipitor in the U.S. was an Indian company called Ranbaxy. It is the largest generic drug manufacturer in India and sells a huge amount of generic medicine in the U.S. Because it was the first off the starting line, Ranbaxy dominates generic sales of atorvastatin. Experts estimate that this Indian company has about 60 percent of the market for the most popular statin-type cholesterol-lowering drug.
That is why it has come as such a shock to learn that Ranbaxy is pulling its 10-, 20- and 40-milligram doses of atorvastatin from the U.S. pharmacy shelves. The problem: 41 lots of atorvastatin were apparently contaminated with small glass particles. You can go to the Ranbaxy website for lot numbers. Here is a link so you can check for yourself.
http://www.ranbaxyusa.com/index.aspx
This is not the first time Ranbaxy has got itself into a pickle. In August, 2008, we wrote the following:
“A story that was virtually ignored by the mainstream press and disappeared almost without a trace has to do with serious allegations against Ranbaxy Laboratories, an Indian drug company. Ranbaxy is not just any drug company. It is the largest pharmaceutical company in India, by sales. The company has huge sales around the world, thanks in large measure to its dominance in the generic drug arena. Not surprisingly, Ranbaxy sells a LOT of meds in the U.S.
“According to reports, Justice Department investigators are concerned that Ranbaxy may have submitted false claims, fabricated documents and committed fraud in drug submissions to the FDA.
“Congress is getting into the act. Leaders of the House Committee on Energy and Commerce have put the FDA on the hot seat, raising questions about what FDA staffers knew about this and when they knew it. There are court documents suggesting that FDA has been aware of trouble at Ranbaxy for at least 18 months. FDA apparently did nothing to warn physicians, patients or pharmacists of the suspected problems.
“If Ranbaxy fabricated evidence for its generic drug applications to the FDA and concealed violations of manufacturing practices, this is a big deal. We have been questioning the ability of the FDA to monitor the quality of generic drugs for several years. (Read some of the reports on this site for frightening examples of apparent generic shortcomings.) We suspected that some companies in China and India may have taken short cuts. If the Ranbaxy mess proves true, we will know that our fears were justified. We wonder how many other problems may not have been detected by the FDA.”

In the fall of 2008 the FDA banned importation of 30 generic drugs (including statins such as pravastatin and simvastatin and the antibiotic ciprofloxacin) from Ranbaxy Labs. The agency cited lapses in manufacturing process and quality control. The U.S. Department of Justice pursued separate action, alleging that Ranbaxy distributed adulterated and misbranded products. In other words, the company was accused of forging documents and fudging key information.
Is it any wonder we have been concerned about generic drug quality? Over the last several years there have been problems with the Actavis Group, which had to voluntarily recall 800 million digoxin tablets [a critical heart medicine] because of doubts about the dose. KV Pharmaceutical got into trouble as did Sandoz and Caraco. Over 100 different generic drugs have been recalled over the last few years, resulting in drug shortages of key medications.
WHAT’S A PATIENT TO DO?
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. Ask your pharmacist whether you can bring or send (in the case of mail-order) the pills back in return for either Lipitor or non-recalled generic atorvastatin. 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.
To learn more about the generic drug problem in the U.S. you may want to read our chapter, “Generic Drug Screwups” in our book Top Screwups Doctors Make and How to Avoid Them. You will learn details about our
Top 10 Tips for Taking Generic Drugs:
1. Make no assumptions
2. Keep track of the manufacturer
3. Keep records
4. Ask for your lab results
5. Monitor symptoms
6. Listen to your body
7. Challenge and rechallenge
8. Be assertive
9. Seek allies
10. Report any problems to the FDA

We are having a special Black Friday 20% sale (that extends through Monday) on every publication and product in our People’s Pharmacy Store.
Use the code BLKFRIDAY to savor savings of 20%. That includes the book, Top Screwups.
BOTTOM LINE:
The removal of Ranbaxy’s atorvastatin is just the latest in a long line of generic recalls over the last few years. On top of the generic methylprednisolone injections that were contaminated with fungus at the Massachusetts compounding pharmacy, we are left with grave doubts about the ability of our federal (and state) regulators to ensure the quality of our drug supply.
Consumers and patients will need to be ever more vigilant. If you suspect that your medicine is not working as expected, please let us know. Also report any concerns to your physician, your pharmacist and the FDA. Although the agency does not have adequate resources to inspect all drug manufacturing plants abroad, the feds do have the responsibility to pay attention to patients who report difficulties and then make an honest effort to track down the source of the problem.
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  1. Linda G
    Reply

    I have used LIPITOR brand name for 10 yrs now without any problems. I had to switch to another Dr when my husband got laid off from his job. They gave me generic Lipitor. Otherwise I would have to pay the $200.- co-pay for name brand. I took GENERIC for about ONE month when I started feeling very stiff and pain all over my body. So I decided to get off it and Lipitor for now. Before switching to KAISER I paid only $4.00 ea mth for brand name Lipitor, Kaiser does not honor the Pfizer discount card. We should be able to get brand name drugs without very high co-pays. We are being forced into generics who do not work for us.

  2. WDO
    Reply

    I am not surprised by this. I have told CVS that I do not want any drugs from that are manufactured by this company or any other company not regulated by the FDA. They Paid no attention to my request and sent my latest med. made by Ranbaxy. I am not happy about that. I do not want to get any medication that is not Made in the USA and the facility approved by the FDA.

  3. ncp
    Reply

    Thanks for this information. This is quite shocking but reinforces my belief that we have to always be on the look-out for our own and our family’s health.

  4. cbw
    Reply

    I had 30 pills left of a 90 day supply and CVS said they had no way of tracing what lot number my prescription was from, although they did say they had some of the lot numbers from Ranbaxy Atorvastatin and they had pulled them from the shelf. They offered to replace the pills I still had with pills from another supplier of Atorvastatin.
    I don’t understand how we (USA) can track lot numbers of peanut butter, lettuce, etc and the consumer has no way of knowing if they have taken pills from the recalled lot numbers and the pharmacies are not required to pass the lot number on to the user or keep track of it in their computer system.

  5. a.s.
    Reply

    there are, dear “rkatrin,” any number of NATURAL treatments for high cholesterol. i’d be willing to bet that this very website and the attached bookstore will reveal a large number of them. i took my cholesterol from 250+ down to less than 175 in six weeks using a number of supplements in combination. check it out.

  6. bg
    Reply

    I agree with c.s. WHY are we buying drugs from other countries? Why can’t we manufacture all our drugs? I understand the negative view that many people have toward the pharma companies but at least we can depend on them more than a company like Ranbaxy thousands of miles away, without any control from the U.S.
    This is a real eye opener for me; after reading the all the comments posted I didn’t realize how in the dark I have been! From now on I will check the meds I am prescribed and keep a record along with where they came from. I haven’t even read anything about atorvastatin in the local papers here in NYC.
    We have to keep vigilant.

  7. CKD
    Reply

    You do not include the most important information for patients to determine whether their atorvastatin is recalled or not: What is the relation of the other manufacturer, Watson, to the lots that have been recalled. CKD, MD

  8. Vic
    Reply

    My local Rite Aid, source of my Atorvastatin by Ranbaxy, said they did not keep track of lot numbers. And besides, the recall is only at the retail level, not the user level. That made me feel a lot better.

  9. r m l
    Reply

    Asking about recall of liptor. need more information. thank you.

  10. rmkr
    Reply

    I called the WALMART here in Vero Beach this a.m….My question to their pharmacy–Does WALMART buy their ATORVASTATIN from RANBAXY pharmacy? and added that there was a recall……………
    I was told that they will check it out “call back in a few hours”!!!!!!!!

  11. Naomi B.
    Reply

    Hi folks,
    I really enjoyed the comment from BR on Nov. 24,but was a bit puzzled when she/he mentioned “worth” in relation to your newsletter. I’m not paying anything. Is there some (print)publication that I haven’t seen? Please let me know, as I think your computerized info is worth a million. I just called my WalMart pharmacy to check on Ranbaxy and was delighted to find out that they “don’t have a thing from that company” in the store. CVS probably won’t after this.
    Again, thank you so much for the good works you do.
    Naomi B.

  12. BR
    Reply

    I called my CVS, spoke briefly with a pharmacist. He said they had already checked the Lot #s in question and they have had none of them in their inventory. Without your Alert I would never have known to call. Thank you so much. This one Alert is worth my subscription to your newsletter. The Tips are welcome.

  13. CLTSO
    Reply

    It was a relief to check the lot numbers on my husband’s bottle of Atorvastatin and find his lot number was NOT there. Thanks for the heads up.

  14. Valerie
    Reply

    I have been taking Singulair for several years, for asthma and allergy triggered symptoms, primarily pulmonary. A couple months ago the generic version became available and I welcomed it due to the greatly reduced cost. However, within a couple of weeks I began having symptoms – more secretions, more need to use my rescue inhaler, chest pain. Speaking with a friend of mine in the exact same circumstances, she had experienced the same symptoms.
    I have just gone back to the trade name Singulair at a huge price since my insurance thinks I should be happy with the generic. My symptoms are improving. I have not filed a report with the FDA because they seem to only want extreme cases. Can you advise me on what I should do? Essentially I am paying through the nose to defend myself against an inferior drug.

  15. Robert H. S.
    Reply

    I have been taking , as prescribed, CLOPIDOGERAl, or PLavix. I was happy when the Patent ran out, now I am taking a “Generic”, made in Canada, I think…..sure is cheaper, however I hope I can get over having to take ANYTHING!

  16. cs
    Reply

    Why the hell are we buying generic prescriptions from out of our own country in the first place? Do we not have the facilities, mentality nor ability to make even generic pills? Why isn’t the name of the country on the prescription label when we buy the meds? It is our right to know where medications we use every day of our lives are coming from! I don’t know why more Americans are demanding this kind of info. The care where their shoes and sweaters are made, but don’t seem to worry about what foreign country is making their daily dose of “wellness”!!!

  17. jas
    Reply

    After suffering from reactions by generics I’ve taken, I have concluded that the FDA is corrupt and cannot be trusted. I’m sorry, but I’ve had so many bad experiences with generics that were so bad I landed in the ER.
    Somebody is not telling the truth and I guarantee it would point to the FDA and their deep pockets… I would not be surprised if they uncovered bribery and corruption at the FDA. And someone needs to tell the Big Pharm industry that we consumers don’t trust them either!
    They can save their money and stop advertising these new drugs because we consumers don’t trust anything that’s hasn’t been on the market for the last 30 years-plus! We consumers are no longer blind, trusting idiots! (Thanks to courageous whistle blowers like People’s Pharmacy… and others.)

  18. jas
    Reply

    I took a pill form of methylprednisolone and my heart starting pumping so fast I landed in the hospital ER. The orthopeadic who prescribed it for my shoulder pain was totally stumped as to why I was having this reaction. ER doctors tried to slow down my heart rate with other meds but none of them worked…. even the ER doctors were stumped. I’m NEVER, EVER going to take generics ever again!!!
    I’m sure a lot of stuff goes into generics (accidentally and otherwise) that shouldn’t be in those meds… And where’s the quality control in these manufacturing plants? Why can’t the FDA make it a law to have companies hire outside quality control people???? This is utterly absurd!!!

  19. Rkatrin
    Reply

    The use of statins is probably the most outrageous scam in the history of the drug industry. Not only are they unnecessary, the whole cholesterol thing is a joke. There’s absolutely no evidence that lowering cholesterol saves lives, on the contrary, many of the brands have made people sick, debilitated and diseased. So good riddance to statins and keeping the cholesterol myth going by making them generic makes them even more dangerous. These drugs should have been outlawed a long time ago, just another, maybe the worst, example of medical maltreatment in cahoots with the immoral and dangerous drug industry in this country and now worldwide.

  20. Helene J.
    Reply

    Thanks for the information about atorvastaton….My mailorder RX company had recommended that but I declined and chose another product… lucky me.!

  21. ml
    Reply

    I take the generic for Aromasine–exemestane. The brand product was in the 850.00-900.00 range for three months. The generic price is still 185.00 for three months. When I investigated, I found it is still manufactured by the original pharmacy and distributed by only one other generic pharmacy. No competition, still a high price.
    Have you heard of this happening before?

  22. BT
    Reply

    I had successfully used the generic Enalapril for Vasotec for several years. Then I began having erratic symptoms with high blood pressure.
    I found that my generic was made by Ranbaxy. A pharmacist had told me that Ranbaxy was one of the top manufacturers in India.
    After checking, I found that Ranbaxy had been producing drugs that were not up to standards. A large quantity had been confiscated in the Pacific.
    I switched to Vasotec and my drug plan would not pay for the brand name. It was very costly. It took a very long time to achieve stability
    with my blood pressure. Lesson learned: In the absence of adequate oversight by the FDA the consumer must be diligent.
    Also, I had a very bad reaction requiring hospitalization, after being prescribed Potassium Chloride while on Enalapril. Independent research,
    and the help of Joe Graedon at People’s Pharmacy, probably saved my life. It seems that Potassium Chloride, when taken with Enalapril, has been fatal particularly among the elderly. Incidentally I found that Potassium Chloride is in many nutritional supplements such as Boost and Ensure. It is also in some
    bottled waters!
    Thankfully Enalapril, made by a reliable manufacturer, is working fine!

  23. KK
    Reply

    I am hypothyroid. My endocrinologist was adamant that I use only brand name levothyroxine, such as Synthroid, since he had experienced many examples of his patients taking the generic version and not reaping the benefits as demonstrated by their blood lab values. Now since my insurance company only covers generic and not brand I am forced to buy by prescription Synthroid in Canada.
    Generic medications need to be vigorously tested before being released to the public and our FDA needs to be overhauled.

  24. Sal
    Reply

    Just as many, many others, this latest report comes as no surprise. After successfully treating my intermittent irregular heart rhythm problems with Tiazac, my insurance company basically forced me to go with a generic manufactured in India.
    Within 10 days it became apparent that the generic was not working and my only option was to return to the name brand and its large co-pay. For the record, I did report this to the FDA but I honestly don’t expect anything to happen. I also reported the problem to Consumers Lab which has a program of their own that is trying to identify bad generics…

  25. DPH
    Reply

    Our wonderful old GP told me that he had seen such mixed results with generics that he recommended that if I wanted to try a generic that I should monitor my reaction for any unusual changes.

  26. lab
    Reply

    I hope this does not become a “blame the patient” story, about how we should have done better to let our doctors know about problems with generics. We have! And we have been told over and over that the generic is just the same as the original drug. We’re treated like idiots when we insist that it is not. Now this story. Blame the doctors for not listening to us.

  27. Gt
    Reply

    I have wondered for a long time why a major manufacturer will not sell their brand name product at a competitive price to the generic once the product has lost it’s patent? I was also on norvasc successfully for many years and finally had to switch to the generic, I willingly paid the higher price for a while but it just got to be too much. I think people would pay a slightly higher price for the brand name if the difference between generic and brand wasn’t so great and the original manufacturer wouldn’t lose so much of the market. Is there an explanation? Thanks

  28. JB
    Reply

    Well, big surprise! I have had problems with generic drugs for years, which started with congegated estrogen (for Premarin) many years ago. That was pulled off the market because they finally found it did not work. I have also had trouble with generic Norvasc and Labetalol. I reported the generic Norvasc to the FDA,after a serious side effect, as well as my insurance company and the manufacturer picked up what was left of my pills to examine them and guess what,said they found nothing wrong with them. We are at the mercy of the Pharmaceutical companies and the greedy insurance companies who make us buy generic instead of brand name drugs.

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