The People's Perspective on Medicine

Chinese-Made Losartan Recall | More Cancer Concern

First came a valsartan recall because of suspected carcinogen contamination. Then irbesartan was recalled. Now there is a losartan recall. What's going on?

No, no, no, no no! Not again!! Just last week we said “Not Again” when we learned that that some formulations of the blood pressure drug irbesartan were contaminated with the impurity NDEA (N-nitrosodiethylamine). This probable carcinogen had been introduced during manufacture of the ARB (angiotensin receptor blocker). The active pharmaceutical ingredient (API) was made in India by Aurobindo Pharma Limited. Before that, there was a valsartan recall. And now there is a losartan recall. What the heck is going on?

Generic Cozaar | Losartan Recall

We are told that another generic ARB, losartan, is being withdrawn because of concerns about a probable carcinogen introduced during manufacture. This is getting ridiculous! On November 9, 2018 we discovered that the:

“FDA is alerting patients and health care professionals to Sandoz’s voluntary recall of one lot – JB8912 – of losartan potassium and hydrochlorothiazide 100mg/25mg tablets, that contain losartan, an angiotensin II receptor blocker (ARB), and hydrochlorothiazide, a diuretic, used in combination for the treatment of hypertension. Sandoz’s product was made using an active pharmaceutical ingredient (API) that has tested positive for NDEA. The API was manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd, which is on import alert.”

So far, the FDA reports that “less than 1 percent of the total losartan drug products in the U.S. market” have been affected by the losartan recall. That might seem reassuring, but the valsartan recall started out seemingly small. It grew and grew until we lost count of the number of companies that were affected. We will be very interested to see whether this losartan recall spreads like the valsartan recall.

The Cast of Characters:

What is especially bizarre about this new warning is the cast of characters. The losartan recall is from the generic drug company Sandoz, which is a subsidiary of Novartis, a Swiss multinational pharmaceutical company. The active pharmaceutical ingredient (the real medicine) was made in China by Zhejiang Huahai Pharmaceutical Co. Ltd., the same Chinese company that made the contaminated valsartan.

We issued a special People’s Pharmacy Health Alert back oh July 15, 2018 because of cancer concerns.  At first it seemed like a relatively small recall, but over the summer the FDA issued more announcements about recall after recall. More manufacturers were caught up in the web.

China at the Center of the Storm!

The Zhejiang HuaHai Pharmaceutical Company in Linhai, China made the valsartan that was distributed to other drug manufacturers all over the world. Regulators in Europe, Japan, Hong Kong, Taiwan, Canada and the U.S. ordered recalls of various valsartan products. Here is a list of manufacturers that had problems with their valsartan products.

The Valsartan Recall Disaster Keeps Getting Worse, Not Better

But Wait…It Get’s More Complicated.

The finished losartan pills that were recalled by Sandoz were not made in China. They were actually formulated in Ljubljana, Slovenia by Lek Pharmaceuticals dd. This company took the API losartan from Zhejiang HuaHai in China, added hydrochlorothiazide from goodness knows where and turned these chemicals into Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25 mg. The Lek Pharmaceutical company presumably shipped its pills to Sandoz, which then shipped them to distributors which then shipped them to U.S. pharmacies.

Are your confused?

You should be. You have to read the FDA’s official announcement to appreciate this bizarre system of drug manufacturing. Here is a link to the FDA’s announcement.

What you are learning is that our medicines are being made all over the world. We suspect that a drug made in China, shipped to Slovenia and then shipped to the U.S. might not get the same FDA scrutiny that a medicine made in Pennsylvania might get.

We also worry about the way inexpensive generic drugs are transported. We have repeatedly asked the FDA if it monitors shipping conditions abroad. The answers we have received are unsatisfactory. Are medicines shipped in temperature and humidity controlled containers? Are they shipped by airplanes or cargo ships? The FDA has not answered our questions in a clear manner. We find that distressing.

Here is an article we have written about the FDA’s answers to our questions about shipping both from abroad and within the U.S.

Should You Worry About Mail-Order Prescriptions?

The People’s Pharmacy Perspective:

We are sick and tired of reading about another ARB recall. We now have the valsartan, irbesartan and losartan recall to contend with. We shall see if more ABRs enter the contamination contest. At the rate we are going we would not be surprised to learn about others.

You may find our interview with Rosemary Gibson of great interest. Her book is titled: China Rx: Exposing the Risks of America’s Dependence on China for Medicine. Here is a link to a one-hour interview on this topic. We think you will find it fascinating. You can listen to the streaming audio for free by clicking on the green arrow above Rosemary’s picture. You can also download the mp3 file for free to play on your computer or electronic device. Here is the link.

We Value Your Opinion

What do you think about the ARB recalls? Share your own thoughts about the manufacturing of generic drugs in countries like China, India and Slovenia. The FDA continues to try to reassure physicians, pharmacists and patients that it has everything under control. The FDA says generic drugs made abroad represent a great savings for Americans. Do you agree?

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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Four years ago I was made ill by Losarten made by Teva. I was hospitalized and recovered after I was put on the hospital’s pills. I became I’ll the day after I started the pills. I contacted the FDA but they were uninterested in checking what was in the pills.

I got a robo-call from my pharmacy to say that my losataran might be under recall. So I called the pharmacist, and he said I would need the lot number and wanted to give me a number to call. I said, “It is still in your store. YOU look up the information.” If food is recalled, they pull it from the shelf and send me a message with the number on the package so I can quickly look it up. If I haven’t already eaten the food.

With these recalls, they seem to expect the customer to do all the work. And I, a person who has already had cancer, have already consumed the drug. So there is nothing I can do. Treating people for cancer because they don’t bother with quality control of drugs is, among other things, very expensive.

So it appears that manufacturing is globalized, to the extent that different components are made in different countries then shipped to another country for final formulation. But oversight is localized and specific to individual nations (the EU being considered as a single country in this).

No wonder the “watchers” keep not seeing. There are too few of them with too many places to watch over. Who can begin to determine how much is missed and for how long? We’re lucky aany of these charlatans gets caught, and then it is only one product and not the manufacturer(s) that are “recalled.”

If the big Pharma companies stopped charging ridiculous prices for their medicine these problems wouldn’t recur. It’s only a small percentage of the world population that has universal healthcare. So there’s no way they can afford the prices charged by big Pharma. We have to buy our medicine from India or China to survive. It’s not only medicine but important medical appliances made in the West that cost several times those made in China. I need a bronchodilator for my asthma. I can buy brand name ones in India for four dollars. When they cost 20 to 30 times more in the US and Western countries.

How does one go about getting a bronchial inhaler from India??? Please share
Please share the information
Thank you very much in advance

And my doctor wonders why I don’t want to take any medication and prefer to use exercise and food to stabilize any challenges that I may have.

I have spent hours online researching U.S. manufactured medicines with no success. (It could be me.) I’ve called multiple pop and mom pharmacies and chains, regarding manufacturers, generic, non-generic, etc., and was told what I see is what I get. This is after the 5th degree of wanting All of my personal information, “was I a customer, where did I live,” wow. I wanted to know if I could purchase the name brand med instead of generic and at the end of these conversations I felt chastised, as if I wasn’t allowed to question the pharmacy about the manufacturer, that I should just ‘trust’ what the pharmacists dispenses. That’s bull. If I don’t question, who will?

Am I going through my elder years following the sheep trail? When did I lose the right to ask a question of a professional regarding something I am not only purchasing but ingesting?

Sadly, 98 percent of our vitamins come from China, as do 100% of vitamins in dog and cat food. Fortunately one can purchase excellent vitamins made in the states online. Wish it was the same for medicines.

There has to be a massive outcry from us to get anyone’s attention. Are we going to continue to sit back while China sells us inferior clothing, shoes, vitamins and medicines without any alternatives? It’s going to get much worse if we don’t pull together. We’re worried about our meds, what will do when it’s our food?

Money is NOT the root of all evil. The LOVE OF MONEY is the root of all evil. ( I Timothy 6:10)

When valsartan was recalled, my physician/pharmacy switched me over to losartan. The pharmacy filled my prescription with losartan mfgd by Solco which is a subsidiary of the Chinese company that made the tainted ingredients for valsartan. One month after I started taking losartan, I developed hives which I still have today. Losartan is the only new drug I’ve started taking this year.

With the great knowledge and expertise of the US Pharmaceutical companies, why is the FDA allowing Chinese products especially with their track record of NO accountability to come into our country?

I get my Lorsartan from Walmart because that is what my Medicare supplemental insurance covers. Do the pharmacists at Walmart have any idea of where there medicines come from? If not, how am I to know? This is very distressing!

I was on Valsartan manufactured by Zhejiang HuaHai in China. I was disgusted when I found this out. I now have cancer but I have no way of finding out if this could have been caused by the Valsartan. After it was recalled, I was put on Losartan manufactured in India. This is just as annoying to me as having my meds come from China. I am convinced that there can never be enough oversight on the manufacture of our meds if they are made in foreign countries. The FDA is letting US citizens down and it is despicable.

I was using Losartan for several years but stopped in May this year after feeling continually tired and with back pain. At this time I also changed my diet to a high protein, low carb way of eating, which caused an electrolyte conflict with the Losartan Potassium. Now after 6 months my BP is normal and I feel great. I’m so glad I stopped when I did, I feel sorry for those still on the drug who now face uncertainty and added stress because of profit driven multi nationals.

There are over 1200 alerts, recalls or withdrawals on the FDAs web site (Torrents was on there) which includes food and drugs. That is remarkable. Thank you Joe and Terry for you hard work to keep us all safe.

‘‘This is beyond dangerous!
When is our FDA going to crawl out of the pockets of big pharma and actually do their job protecting Americans??!
Overseas imports of drugs should be banned unless they are properly tested first to prove their safety before unwitting and unknowing Americans are further harmed by them!

I TOTALLY agree with Elizabeth (CA) @ 2:38 pm!! The only thing the FDA is doing is issuing recalls — after the horses are out of the barn!! I understand globalization, but the FDA should have safeguards in place to prevent these recalls. I’m especially wary of any products made China and India after watching “60 Minutes” over the years.

Saving money is no excuse for accepting substandard and downright dangerous drugs that threaten our health and welfare. The fact is, no one is minding the pharmaceutical store. I’m willing to pay more, even out of pocket, for “clean” prescriptions made here in the U.S. We all know that other countries do not honor the same standards we do. The Valsartan recall was “voluntary,” so notifications or refunds were not required. Ugh!

What can we do as consumers ? I’m sure our doctors don’t have any control before prescribing these generic drugs. With the price of drugs today all drugs sold in this country ought to be certified as reliable and safe. Why can’t these drugs and these ingredients be made in America?

I believe our family physicians are greatly influenced by their drug reps and should include the following questions of these reps: where is this drug manufactured and how is it shipped to the U.S. ? We have recently changed our doctor because he constantly changed the brands of our meds! We kept getting different side effects, and eventually he would put us back on the original he had taken us off of! I find we only trust our pharmacist’s advice.

I feel like this will become a security threat for the U.S. If these “contaminants” are “accidentally” getting into our medicines, what else could be put into them. How many people are taking statins in the U.S.? How easy would it be for these to become “contaminated” with any number of compounds?

I take a statin, my husband takes 2 BP meds (including losartan), and my daughter, who has a brain tumor, takes 5 different meds that are basically keeping her alive. If any of her meds were to be recalled she would die.

We need to get this under control before our meds kill us.

Money is the root of all evil. It seems like drug companies put making money over taking care of people’s lives. Yes, they are making medications that save lives, but if the cheapest ingredients and cheapest companies are used – where is the quality control and testing? Where is the checking on how things are shipped? Sometimes my mail-in prescriptions are left in my mailbox when the temps are over 110 in southern California. Yes, I’m worried about Chinese drugs. I hate the thought that taking one of my blood pressure medications can be making me ill in another way. It’s bad enough for me, and I am very sensitive, to battle side effects but now I have to worry about whether the medication is slowly killing me or damaging my organs.

What is amazing is the outrageous price we pay for drugs in America and find out there is little oversight about where they come from and how they are manufactured. Pharmaceutical companies are out for exorbitant profits at the EXPENSE OF PEOPLE’S HEALTH AND WELL BEING. IT IS ONE OF THE MOST SHAMEFUL PRACTICES ANYWHERE.

I appreciate your pod casts and your radio program. Otherwise I’d never hear of any of these things! I am a Losartan user. I get mine through the V.A. and have contacted them to find their source. The program on our drugs being made in China is extremely maddening, frustrating, no other words to describe it.

Thanks. Will talk to my pharmacist to see if that is why they changed manufacturers recently.

I believe they really mean “At greater profit for pharmaceutical companies,” rather than “at great savings to patients.” I’ve not heard a word about any “sanctions” or “tariffs” on anything to do with the drug world in re: China. I’d imagine that’s because there is great financial gain to those who COULD do anything about it. The top 1% is running the show. They are presumably invested in pharmaceuticals because they are obscenely profitable; they can afford to ensure any drugs THEY take come from a known, approved source, and basically they seem not to care about the average citizen at all.

I’ll ask again. What drugs do any of them take and where do they come from? I’m also curious about how many and what drugs (if any) are made here from ingredients made here, or at least in some country with better regulation and accountability. AND why did the FDA allow this travesty to occur in the first place?

Seems it always comes back to the money.

As a nurse for many years, it is horrible to see that the health of our patients is in jeopardy due to the medications that are prescribed. This situation is due to the greed involved in the production and sale of the medicine. The FDA needs to do it’s job and shut the import of poisoned medication down.

How can we find losartan or valsartan made in U.S.? Is any even made here, and if it is do they really just source the raw materials from China, Slovenia, or some other disreputable country?

I am taking Telmisartan Micardis . So far I have not heard anything about contamination.
I buy it from a mega discount chain store.
I will follow on your website.
Thanks for your alerts.

R.k.M. I wrote to you several years back about my husbands cardiac arrest following a switch from real to generic Plavix made in India. I think it’s not just the current medicines we are learning about that we need to be looking at. There is a very real and life-threatening problem here. Fortunately he came thru his ordeal very well and is one of the lucky few that do.

Is there a concern for Losartan manufactured by a company other than Sandoz? My drug is manufactured by Torrent Pharmaceuticals.

Mine is also manufactured by Torrent. If this plays out like the previous recalls you can bet we’ll be included as well!

Mine is also mfg by Torrent. Please look into this.

I think unless you can tell us how to identify the origin of the losartan to determine if it is contaminated the information is essentially useless to us…

The FDA does not do its job. Period. It would need to have its budget increased exponentially to really protect the public. Or, we’d have to make all parts of the drugs here, and with proper oversight. Now, the FDA is barely a presence in China and India, not to mention Slovenia, etc. In addition, I see this as a national security issue. Do we want essential drugs possibly used as pawns in a trade war or something worse? I think People’s Pharmacy needs to give this looming danger its very fullest attention, to include working with other interested parties. One example would be Consumer Reports.

We have begged Consumer Reports to pay attention to generic drug quality. So far our concerns have fallen on deaf ears. We LOVE Consumer Reports, but the organization has been so totally invested in the value of generic drugs for decades that it cannot bring itself to question the quality of such products. It is truly a shame.

The FDA needs to make an investigation into all our generic meds made in different countries, although this will never happen. Too costly.

I was in the SPRINT study for 4 years. The drug given to me was Losartan, the generic version of Cozaar. I didn’t feel right and complained often about this. The doctors insisted I was doing okay with this drug and changed various diuretics to go with it. Finally I completed the SPRINT study and immediately wanted off Losartan. During the treatment I developed Lichen Planus and then both nummular and regular eczema. I did the unthinkable. I weaned myself off the drugs, and several months later my dermatologist confirmed through biopsies that Losartan was the cause of all my skin disorders. I want drugs made in the USA!!! Please either start a movement or tell us who to write to so we can stop this disgrace and potentially fatal prescription drug issue.

I am outraged that I am taking medicine made in China.

Yes I concur with the audacity of our pharmaceutical regulatory boards not protecting us our elders are taking these medications. But our outrage is displaced. The Pharmacist are also helpless. They too trust the FDA. I really don’t know what to do. However my first call of complaint will be the FDA itself. We should all just keep calling them. Thank you for keeping us informed. Please list the alternatives so we can speak to our physicians

So what are our options? Perhaps the FDA should require that pharmacies put on all prescription receipts the country, state, location/factory of the medicine manufacturer that is being provided to the customer. The FDA should also have a web page on recalls as does the NHTSA has on automobiles, tires, etc. The latter is a free subscription base that automatically delivers information to the subscriber’s email. If this can’t be done by the FDA, then the “cure may be worse than the disease.”

I don’t like it at all. I have been a strong supporter of American-made products forever, and over the past few years I’ve noticed odd sounding names on the bottom of some of my prescription labels. I’ve looked them up and found that they are many Indian pharmacy company names and now we have to deal with Chinese drugs! What gives? I don’t even feed my dog anything other than American made food and treats. Where is the FDA when you need them? Larry K.

How do I find out if losartan prescription is suspect? Is the pharmacy able to notify individual consumers if their prescription is from a tainted lot?

Also – most generics are really cheap . I would pay more to be assured the drug is manufactured under US rules, preferably in the US.

I was using a bad batch of Valsartan. What I did was go online, and put in “Lists of Valsartan Products under recall- FDA”. I was then brought to a site that listed pharmaceutical companies and the tainted batches. I cannot remember if one of the pages listed the tainted batches and another page had safe batches listed. If you get to the site, search around. It will be clearly stated which is which. You need to know the NDC number. It’s a long number . In my case it was NDC#59746036390 and also the name of the pharmaceutical mfg’s name. This info is on your prescription bottle. Once on the site, you look up the pharmaceutical name and listed below it will be the NDC numbers. I originally had a tainted batch and with every new blood pressure prescription, I check these lists first. The lists are updated frequently. If for some reason you cannot find the NDC number, call your pharmacy and they have to supply that info to you. Hope this helps!

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