Does losartan cause cancer

The agency has also created a page that lists the drugs that have not been recalled.

Losartan. In December, the FDA announced a voluntary recall of losartan potassium tablets USP. An addition eight lots of Torrent Pharmaceuticals’ losartan tablets were added to a previous recall in January. See which products were affected by the recall.

In November, the FDA announced a voluntary recall of losartan potassium/hydrochlorothiazide, 100 mg/25 mg tablets in 1,000-count plastic bottles, NDC 0781-5207-10, Lot number JB8912, Exp. Date 06/2020.

Torrent’s recall was expanded on Jan. 22 to include 10 additional lots of losartan potassium tablets, and six lots of losartan potassium and hydrochlorothiazide tablets. Torrent further expanded the recall in April for 36 more lots of losartan potassium tablets and 68 lots of losartan potassium/hydrochlorothiazide tablets. In September, Torrent announced that an additional three lots of losartan potassium tablets in 100 mg and 50 mg doses, and two lots of losartan potassium/hydrochlorothiazide tablets 50 mg/12.5 mg, and 100 mg/25 mg are being recalled as well. See the full list here.

Macleods Pharmaceuticals Limited on Feb. 25 recalled one lot of losartan potassium/hydrochlorothiazide combination tablets 100mg/25mg, with a July 2019 expiration date. Macleods on June 26 also recalled 32 lots of losartan potassium including two lots of 50 mg tablets and losartan potassium/hydrochlorothiazide tablets, including 12 lots of 50 mg/12.5 mg strength, three lots of 100 mg/12.5 mg and 15 lots of 100 mg/25 mg strength.

Camber Pharmaceuticals on Feb. 28 recalled 87 lots of losartan tablets USP 25mg, 50 mg and 100 mg. See the affected products and what the label looks like.

Legacy Pharmaceutical Packaging, LLC on March 15 recalled 43 lots of losartan tablets. On April 24, the company recalled an additional lot of 50mg losartan tablets. See a list of affected products here and here.

Teva Pharmaceuticals USA on April 26 recalled 35 lots of losartan potassium tablets (6 lots of 25 mg pills and 29 lots of 100 mg) that were sold exclusively to the Golden State Medical Supply of Camarillo, CA. Golden State re-packages the tablets under its own label for retail sale. Teva expanded this recall on June 10, 2019, with another six lots of losartan potassium USP tablets in 50mg and 100mg strength. See all the affected products here.

Ask the doctor: Should I be worried about my blood pressure medication causing cancer?

Published: January, 2011

Q. I heard about a study that found that ARBs can cause cancer. I am taking one, Cozaar, because of high blood pressure. Should I stop taking it?

A. ARB stands for angiotensin-receptor blocker, a class of medications that is used to control high blood pressure, treat heart failure, and prevent kidney disease in people with diabetes or high blood pressure. ARBs are often prescribed when an ACE inhibitor isn’t effective, or the side effects are intolerable. The generic name for Cozaar is losartan; the generic names for ARBs end in –sartan: candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), and so on.

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  • Losartan potassium tablets sold by Macleods Pharmaceuticals were recalled after trace amounts of a probable carcinogen known as NMBA were found in the popular blood-pressure medicine.
  • “The risk of developing cancer in a few patients following long-term use of the product cannot be ruled out,” the FDA noted.
  • Since 2018, there have been at least 19 recalls by manufacturers of versions of losartin over cancer fears,
  • The losartin recall follows similar recalls of the heart drug valsartan, also prescribed to treat blood-pressure issues.

Americans who take prescription drugs to control blood pressure should check their medical cabinets once again. Macleods Pharmaceuticals is recalling another 32 lots of widely used losartan potassium tablets sold nationwide after finding trace amounts of a probable carcinogen.

The recall involves losartan and potassium/hydrochlorothiazide combination pills found to contain N-Nitroso-N-methyl-4-aminobutyric acid, or NMBA, according to a notice posted by the U.S. Food and Drug Administration.

“Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out,” the notice stated.

NMBA is a naturally occurring substance in certain foods, drinking water, air pollution and industrial processes, and has been classified as a probable human carcinogen by the International Agency for Research on Cancer.

The impurity was detected in an ingredient made by India’s Hetero Labs, among the overseas manufacturers tied to a series of recalls over the past year. The latest recall is the second for the same reason by Macleods Pharmaceuticals, which in February recalled another lot of its combination tablets.

Since 2018, there have been at least 19 recalls by manufacturers of versions of losartin over cancer fears, including a March recall of 87 lots of losartin made by Camber Pharmaceuticals.

The FDA cautions that consumers should continue to take their blood-pressure medication regardless of whether it’s been recalled until they can consult with their physician.

FDA expands recall on blood pressure drug valsartan due to probable carcinogen

The federal agency last week said it was reviewing the findings of online pharmacy Valisure, which told the FDA it had detected another cancer-causing chemical in blood-pressure pills made by companies including Novartis. The week-ago filing to the FDA involved dimethylformamide, or DMF, a solvent detected in the heart drug valsartan, according to Valisure.

Multiple versions of generic valsartan have been recalled since last summer, when NMBA was found in a Chinese-made version of valsartan, as drug that for decades has been used to treat hypertension.

The latest recall involves the following lot and batch number and the expiration dates on the packaging:

Losartan potassium tablets 50 mg:

  • BLl711A, BLl710A, November 2019

Losartan potassium and hydrochlorothiazide tablets 50 mg/ 12.5 mg:

  • BLK719A, BLK720A, BLK721A, BLK722A, BLK723A, BLK724A, September 2019
  • BLK725A, BLK726A, October 2019
  • BLK804A, BLK806A, January 2020
  • BLK825A, BLK826A, October 2021

Losartan potassium and hydrochlorothiazide tablets 100 mg/ 12.5 mg:

  • BLM716A, BLM717A, July 2019
  • BLM719A, BLM720A, August 2019
  • BLM721A, BLM722A, September 2019
  • BLM723A, BLM724A, BLM725A, October 2019
  • BLM726A, November 2019
  • BLM802A, BLM803A, December 2019
  • BLM825A, BLM826A, BLM827A, September 2021

Losartan potassium and hydrochlorothiazide tablets 100 mg/ 25 mg:

  • BLM716A, BLM717A July 2019
  • BLM719A, BLM717A, July 2019
  • BLM719A, BLM720A, August 2019
  • BLM721A, BLM722A, September 2019
  • BLM723A, BLM724A, BLM725A, October 2019
  • BLM726A, November 2019
  • BLM802A, BLM803A, December 2019
  • BLM825A, BLM826A, BLM827A, September 2021

More blood pressure medicines recalled over possible cancer-causing impurity

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The Food and Drug Administration posted information on its website listing the blood pressure medications recalled for containing carcinogens. Here’s what to watch out for. USA TODAY

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A recall of common blood pressure medication losartan has been expanded for a fifth time after manufacturer Torrent Pharmaceuticals found a possibly carcinogenic impurity in more batches of the drug, federal health officials said.

Three additional lots of losartan potassium tablets and two additional lots of losartan potassium/hydrochlorothiazide tablets were under recall, the U.S. Food and Drug Administration said Thursday.

The lots contained levels of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above the acceptable daily intake levels determined by the FDA. NMBA is a “potential human carcinogen,” the FDA says.

The recall comes amid a larger string of recalls of blood pressure medications valsartan, losartan and irbesartan that contain trace levels of carcinogens NMBA, N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA), the FDA says.

  • To check to see if your medication has been affected,

Hundreds of lots of the medication have been recalled since last July.

The drugs, angiotensin II receptor blockers (ARBs), work by widening or relaxing blood vessels, thus lowering blood pressure. However, not all ARBs have been affected, and patients should continue to use their medication, the FDA says.

Heartburn drugs: FDA finds probable carcinogen in Zantac and other heartburn drugs

“The risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment,” federal health officials wrote in a statement.

The FDA has said the contaminants likely resulted from a manufacturing change adopted by factories in China and India that make the drug ingredients. The manufacturing change may generate the contaminants “when specific chemicals and reaction conditions are present” and can result of reusing materials such as solvents.

In January, the agency admitted that some versions of the drug valsartan contained trace amounts of a carcinogen for four years before regulators detected the impurity last summer.

New generic: FDA approves new valsartan generic to counter shortages of the blood pressure drug

However, FDA officials said the cancer risk for any person who took valsartan that had the carcinogen N-nitrosodimethylamine, or NDMA, is small. FDA scientists concluded there would be one more cancer case above average rates for every 8,000 people on the highest dose of valsartan for four years.

Contributing: Ken Alltucker. Follow USA TODAY’s Ryan Miller on Twitter @RyanW_Miller

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4 questions and answers for consumers about FDA’s recent high blood pressure medication recall

You may have recently heard that FDA has recalled several blood pressure medications. You may have questions, we have answers.

Reminder: Don’t stop your medicine without contacting your healthcare provider .The risk of abrupt discontinuation of BP drugs can be significant. If you take a medication that has been recalled, your healthcare provider will discuss alternative medications to manage your condition

  1. What medications are included in the current recall?

    FDA has issued a recall of certain lots of angiotensin II receptor blocker (ARB) high blood pressure medication containing valsartan, losartan, or irbesartan. This includes some combination tablets which contain valsartan and amlodipine or valsartan, amlodipine, and hydrochlorothiazide.

  2. Why are these medications being recalled?

    These medications are being recalled due to the presence of N-Nitrosodiethylamine (NDEA) or N-Nitrosodimethylamine (NDMA). NDEA and NDMA are industrial contaminants and both are on lists of chemicals suspected to cause cancer in people.

  3. Is my medication being recalled?

    FDA maintains the most current lists of drugs that are being recalled and those that are not included in the recall.

    In a recent statement, the FDA reminded consumers of the following:

    • It also is important to know that not all ARBs contain NDMA or NDEA, so pharmacists may be able to provide a refill of medication not affected by the recall, or doctors may prescribe a different medication that treats the same condition.
  4. Does my blood pressure medication cause cancer?
  5. This recall is occurring because an impurity has been found in certain batches of this medication. Not all medications are included in the recall.

FDA has provided 4 key takeaways of this recall for patients to know:

  • Continue taking your current medicine until your healthcare provider or pharmacist gives you a replacement or a different treatment option.
  • Not all valsartan-, losartan-, or irbesartan-containing medications are affected and being recalled.
  • If you are taking any medication containing valsartan, losartan or irbesartan, compare the information on your prescription bottle with the information in this list (company, National Drug Code, lot number) to determine if your current medicine has been recalled. If you are not certain, contact your pharmacist.
  • If you have medicine included in the recall, contact your pharmacist. The pharmacist may be able to provide you with valsartan made by another company. If not, contact your healthcare provider immediately to discuss other treatment options.

If you have any additional questions about this recall, FDA has provided a list of questions and answers here. You can learn more about high blood pressure at www.heart.org/hbp.

If you are taking the popular blood pressure drug, losartan, you may have seen the news reports about contamination. Between November 2018 and April 2019, close to 300 lots of drugs containing losartan were recalled because potentially cancer-causing substances were found in the medications. So far, the recalled losartan products have come from five drug manufacturers.

What is losartan for?

Losartan and losartan potassium are the same medication and belong to a class of drugs called angiotensin II receptor blockers (ARBs). Losartan is prescribed to treat high blood pressure, protect the kidneys in patients with diabetes, lower the risk of strokes, and reduce the risk of death in people with heart dysfunction after suffering a heart attack. Other popular ARBs include irbesartan, olmesartan, valsartan, and telmisartan.

Why were some losartan products recalled?

Some losartan products sold in the US have been recalled because small amounts of NMDA (N-nitrosodimethylamine) or NDEA (N-nitrosodiethylamine) were found. Both substances are known as probable cancer-causing agents. This news follows a long string of recalls that happened last year for valsartan for similar contamination reasons.

Keep in mind: Not all products containing losartan have been recalled. The FDA is working to make sure additional products are not contaminated and don’t become contaminated.

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Which losartan products were recalled?

According to the FDA, about 300 lots of losartan and losartan/hydrochlorothiazide products have been recalled as of April 18, 2019. They were manufactured by these drug companies:

  • Torrent Pharmaceuticals Limited
  • Legacy Pharmaceutical Packaging
  • Camber Pharmaceuticals, Inc.
  • Macleods Pharmaceuticals Limited
  • Sandoz, Inc.

Just because you may take losartan made by one of the manufacturers above does not necessarily mean your medication is affected. Specific product lots involved in the recall are listed on this FDA document.

To find out whether your specific product has been recalled, look for the drug name, manufacturer name, and lot number on the label of your prescription bottle. If that information is not on the bottle, contact the pharmacy that dispensed it to you.

What do I do if I think I have recalled losartan?

  1. Keep taking your medication. If you were prescribed losartan, it’s because you need it to treat a serious medical condition. Keep taking your medication until you and your doctor decide on the safest way to proceed. Remember that not all losartan products were affected by this recall.
  2. Contact your doctor or pharmacist. Contact your health provider to discuss treatment options if you think you have a recalled losartan product. Your next step might be taking a losartan product not involved in this recall or using another medication equally effective for your health condition.
  3. Report issues to the manufacturer and FDA. Always inspect your medications, including all parts of the packaging and devices. If you ever notice your medication doesn’t look or smell right, contact the manufacturer or ask your pharmacist for more information. You can also report any concerns to the manufacturer or directly to FDA’s MedWatch Reporting Program, as they can conduct further investigations.

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  • This story has been updated.

    The Food and Drug Administration is investigating the causes of cancer-causing impurities in multiple blood pressure and heart medications, according to a new report from USA Today.

    ” RELATED: FDA expands recall of heart, blood pressure medication due to cancer risk

    Factory inspections of facilities in China and India in recent months have revealed a pattern of issues regarding drugs valsartan, losartan and irbesartan, either alone or in combination with other drugs.

    The most recent recall involves eight lots of irbesartan manufactured by Zhejiang Huahai Pharmaceuticals.

    “I think we have a federal agency that is overwhelmed in trying to keep up,” Public Citizen researcher and director Michael Carome told USA Today, noting the FDA often prioritizes inspections based on potential risk.

    ” RELATED: Silent Killer: 5 reasons to take a second look at your blood pressure

    The agency has been examining “a backlog of unchecked foreign drug plants” amid the increasing overseas pharmaceutical industry actors, including China’s Zhejiang Huahai Pharmaceutical and India’s Hetero Labs, both of which have been forced to recall carcinogen-tainted drugs.

    But exacerbated inspection policies, investigations or recalls don’t guarantee prevention or action from drug companies to correct the problems.

    Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, told USA TODAY the agency isn’t running those manufacturing plants. “Really, a lot of responsibility is on the people who manufacture and offer these drugs for sale,” she added.

    ” RELATED: This common blood pressure medication linked to greater lung cancer risk, study says

    More at USAToday.com.

    Previously:

    India-based drug company Torrent Pharmaceuticals last week recalled an additional eight lots of losartan potassium tablets in addition to the two it recalled in December.

    The FDA shared a notice announcing the the blood pressure and diabetic kidney disease medication contained unacceptable levels of the human carcinogen N-nitrosodiethylamine.

    India’s Hetero Labs has had to recall several commonly prescribed blood pressure drugs since July, including versions of losartan, valsartan and irbesartan. Find a full list of recall-related FDA updates at fda.gov.

    Losartan potassium hydrochlorothiazide (Losartan) was also recalled by Sandoz Inc. in November over cancer concerns due to an impurity impurity N-nitrosodiethylamine, according to the U.S. Food and Drug Administration.

    ” RELATED: Is your medical provider taking your blood pressure all wrong? Experts say probably

    “This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC),” agency officials wrote in the Nov. 8 news release.

    The Sandoz Inc. recall involved 100 milligram/25 milligram Losartan tablets with the lot number JB8912 and expiration date of June 2020. The affected product was not distributed prior to Oct. 8, 2018, according to the FDA.

    The agency recently recalled two other blood pressure drugs for the impurity, irbesartan and valsartan. Those who take these hypertension medications should consult with a doctor or pharmacist before discontinuing use of the drug.

    ” RELATED: Half of US adults now have high blood pressure, based on new guidelines

    The American Heart Association in January announced new guidelines that lowered the threshold for high blood pressure, adding 30 million U.S. adults to the bucket of those with a condition that now affects nearly half of the American adult population.

    For decades, high blood pressure was determined with a top reading of at least 140 or a bottom one of 90. According to the new guidelines, a reading of 130/80 is considered high blood pressure, a change that adds 30 million U.S. adults to the bucket of those with the condition.

    Read the full FDA announcement at FDA.gov.

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    Your subscription to the Atlanta Journal-Constitution funds in-depth reporting and investigations that keep you informed. Thank you for supporting real journalism.

    The Food and Drug Administration has recently recalled a number of blood pressure medications after discovering that they contained potential cancer-causing contaminants.

    In the latest case, detailed on Monday, Torrent Pharmaceuticals Limited expanded its voluntary recall for losartan potassium tablets and the combination medication, losartan potassium/ hydrochlorothiazide tablets. Other lots of losartan as well as other drugs from several manufacturers have been recalled voluntarily in recent months as well due to contamination from other chemicals.

    The drugs from Torrent, with lot numberslisted on the FDA website were believed to be contaminated with “unacceptable” amounts of N-methylnitrosobutyric acid or NMBA, a potential human carcinogen.

    Losartan, a blood pressure medication in the angiotensin II receptor blocker (ARB) class, helps reduce blood pressure by preventing blood vessels from narrowing or constricting.

    A rep at Torrent Pharmaceuticals Limited said that “no adverse events have been reported yet.”

    Per the FDA website, people taking these medications are encouraged to continue taking their medication “as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.” They are asked to consult their physicians or pharmacists before making any changes to their medication regimen.

    Torrent Pharmaceuticals Limited said it suspects that contamination is related to manufacturing at a specific site and is therefore working on “manufacturing and distributing new pills without the contaminant.”

    The rep urged that anyone who is taking these medications should call Torrent Pharmaceuticals Limited at 1-888-280-2040. The company has shared that they will take back contaminated medications and provide refunds.

    FDA has recalled multiple blood pressure medications

    Over the past year, the FDA has recalled multiple blood pressure medications from several manufacturers after discovering potential carcinogens in some batches. It’s believed they became contaminated during the manufacturing process.

    The recalled medications include specific “lots” of losartan, irbesartan, valsartan and combination drugs with valsartan. The investigation is ongoing and the FDA continues to update the list of medications being recalled here.

    Some of the recalled lots contain a combination of medications. Although neither amlodipine nor hydrochlorothiazide are currently under recall on their own, they are when combined with some other medications. For example, a combination of valsartan, amlodipine and hydrochlorothiazide is one product that has been recalled. The FDA website provides lists of valsartan products under recall, valsartan products not under recall, irbesartan products under recall and losartan medications under recall for patients, health care providers and pharmacists to accurately confirm which products are affected.

    Those voluntary recalls came after the discovery of the chemicals NDMA and NDEA — both probable human carcinogens — at levels far above what the FDA considers an acceptable daily intake. NDEA is a naturally occurring chemical in some foods and it can be found in drinking water, but it’s also present in air pollution and industrial processes. NDMA is a chemical that forms in both industrial and natural processes.

    With that said, here are some things you should know if you’re taking these medications.:

    You shouldn’t stop taking the medication until you speak to your doctor first.

    To date, none of the manufacturers have received any reports of people who use these medications becoming ill. If you’re taking a blood pressure medication that was recently recalled, do not stop taking it.

    The FDA says that “the risk of harm to someone’s health may be higher if one of these medications is stopped immediately without any alternative treatment.”

    So, if you’re taking one of these medications, reach out to your pharmacist or physician to discuss alternative treatments.

    These medications will lower your risk for heart disease.

    These medications are for high blood pressure and fall in a drug class known as angiotensin receptor blockers (ARBs). They work by blocking the production of a natural hormone called angiotensin II, which narrow your arteries, raising blood pressure. High blood pressure, which is also called hypertension, causes stress on your heart and can contribute to heart disease.

    High blood pressure affects 75 million American adults.

    High blood pressure is one of the most common medical conditions. Blood pressure is a measure of how efficiently our hearts push blood through our arteries. If the pressure is too low, there is a risk that organs will not get enough blood. If the pressure is too high, there’s a risk that the heart will work too hard.

    Normal blood pressure fluctuates.

    Blood pressure measurements are actually two measurements: systolic, which is when the heart squeezes blood through the body, and diastolic, which is the pressure of blood when the heart is at rest.

    If your doctor says your blood pressure is 130/80, the 130 would be systolic and the 80 would be diastolic.

    While your target blood pressure is often determined by your age and medical conditions, most doctors recommend keeping it around 120/80.

    Several reasons people get high blood pressure and why it’s normal for it to fluctuate

    It’s important to understand that your blood pressure measurement will vary throughout the day; it’s normal. High blood pressure can develop for several reasons, including having a family history, obesity, smoking, high-salt diets, diabetes, lack of exercise and underlying kidney disease. Often, it can be controlled with a combination of lifestyle modifications and a variety of medications.

    Tulsie N. Patel, MD is a chief resident in psychiatry from Dallas, TX, working with the ABC News Medical Unit. Dr. Sumir Shah is an emergency medicine physician and Dr. Saumya Dave is a resident physician in psychiatry and they both are members of the ABC News Medical Unit which can be reached @ABCNEWSHealth.

    FDA recall on Losartan, a popular blood pressure medication. Photo/Carol Robidoux

    WASHINGTON, D.C. – The U.S. Food and Drug Administration has issued a recall on a popular blood pressure medication, citing that a “bad batch” may include a carcinogen.

    The announcement issued Nov. 8 is posted on the FDA website, describes the voluntary recall on behalf of the manufacturer, Sandoz Inc. According to the recall, the tainted product was distributed after Oct. 8, 2018.

    This is not the first recall of blood pressure medication for similar reasons.

    The FDA recently recalled blood pressure drug irbesartan for the same defect. That product callback followed on another NDEA-related drug recall, for another blood pressure medication, valsartan, in July.

    As with previous recalls, the FDA cautions that if you take these hypertension medications, it is important to consult a pharmacist or physician before discontinuing use of the drug, as that may have even more severe effects than taking a contaminated pill.

    Sandoz Inc. is voluntarily recalling one lot of Losartan Potassium Hydrochlorothiazide Tablets, USP 100mg/25mg to the consumer level. This product is being recalled due to the trace amount of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Losartan, USP manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz Inc. Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC).

    To date, Sandoz Inc. has not received any reports of adverse events related to this lot.

    Losartan Potassium Hydrochlorothiazide Tablets, USP are indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. The product can be identified as Losartan Potassium Hydrochlorothiazide, 100 mg/25 mg tablets in 1000-count plastic bottles, NDC 0781-5207-10, Lot number JB8912; Exp. Date 06/2020. This product was distributed nationwide to distributors. The affected product was not distributed prior to October 8, 2018.

    Sandoz Inc. is notifying its distributors by letter via overnight mail and patients by this public notification. Distributors and retailers that have product which is being recalled should immediately stop distribution of the identified lot above and quarantine any quantities remaining in your control and return the recalled product to the identified Reverse Distributor.

    Patients with questions regarding this recall can contact Sandoz Inc. at 1-800-525-8747 Monday-Friday 8:30 AM – 5:00 PM (EST) or email [email protected] Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on Losartan Potassium Hydrochlorothiazide should continue taking their medication, as the risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using Losartan Potassium Hydrochlorothiazide.

    Adverse reactions or quality problems associated with the use of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

    • Complete and submit the report Online: www.fda.gov/medwatch/report.htm
    • Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

    This recall is being made with the knowledge of the Food and Drug Administration.

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