Irbesartan 150mg. NDEA and NDMA can be unintentionally introduced into manufacturing through certain chemical reactions. 00:33. Aurobindo Pharma USA … irbesartan recall list: irbesartan recall solco: irbesartan recall 2018: irbesartan side effects: fda irbesartan recall list: fda irbesartan recall: 12 3. Irbesartan Recall Lawsuit. Not all valsartan, losartan, and irbesartan-containing medications are affected and being recalled. 2.1 General Considerations. 2 years ago. A list of ARB medications affected by the recall are available on FDA’s website for healthcare professionals and patients to monitor. Hetero Labs, Inc., labeled as Camber Pharmaceuticals, Inc. Legacy Pharmaceutical Packaging, LLC (Hetero/Camber), Legacy Pharmaceutical Packaging, LLC (Torrent), Losartan/Hydrochlorothiazide (HCTZ) 100mg/25mg Tablet, NuCare Pharmaceuticals Inc. (Prinston/Solco), Preferred Pharmaceuticals, Inc. (Torrent), Preferred Pharmaceuticals, Inc., labeled as Solco Healthcare, Prinston Pharmaceutical Inc., dba Solco Healthcare LLC, Irbesartan/Hydrochlorothiazide (HCTZ) 150mg/12.5mg Tablet, Irbesartan/Hydrochlorothiazide (HCTZ) 300mg/12.5mg Tablet, Amlodipine/Valsartan/Hydrochlorothiazide (HCTZ) 10mg/320mg/25mg Tablet, Rising Pharmaceuticals Inc., labeled as Acetris Health, LLC (Aurobindo), ScieGen Pharmaceuticals, labeled as GSMS Incorporated, ScieGen Pharmaceuticals, labeled as Westminster Pharmaceuticals, Amlodipine/Valsartan/Hydrochlorothiazide (HCTZ) 5mg/160mg/12.5mg Tablet, Amlodipine/Valsartan/Hydrochlorothiazide (HCTZ) 10mg/160mg/12.5mg Tablet, Amlodipine/Valsartan/Hydrochlorothiazide (HCTZ) 10mg/160mg/25mg Tablet. You can find a comprehensive list of all recalled … Drug Safety and Availability, Recalls, Market Withdrawals and Safety Alerts, Information about Nitrosamine Impurities in Medications, Medication Errors Related to CDER-Regulated Drug Products, Postmarket Drug Safety Information for Patients and Providers, Risk Evaluation and Mitigation Strategies | REMS, Multistate outbreak of fungal meningitis and other infections, Recalls of Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan. Report any unexpected side effects with ARB-containing medicines, to FDA’s MedWatch program to help the agency better understand the scope of the problem: Return it to your pharmacist when you get your new medication. Because not all valsartan and irbesartan drugs are involved in the recall, you might be able to switch to a version by another company. Irbesartan is slightly soluble in alcohol and methylene chloride and practically insoluble in water. The agency also updated the list of irbesartan products under recall. The site is secure. Blood Pressure Medication Recall: Irbesartan. Laval H7L 3W9 Quebec CANADA Next 29 results. Irbesartan and Irbesartan-containing Products Recall - Raw Ingredient May Contain a Potential Carcinogen – Updated Apr 5, 2019 8:03 AM In January 2019, Prinston Pharmaceutical Inc. recalled tablets of irbesartan and irbesartan co-formulated with hydrochlorothiazide. Beginning in Summer 2018, FDA learned and reported that some generic versions of the angiotensin II receptor blocker (ARB) medicines contain nitrosamine impurities that don’t meet the agency’s safety standards. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. KGUN - … Currently, the recall affects only medications containing valsartan, losartan, or irbesartan. The recall follows a Europe-wide investigation into contamination of sartan products. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Irbesartan is an angiotensin II receptor blocker (ARB) indicated for treatment of hypertension, to lower blood pressure.Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Recent FDA Alert(s) for candesartan Angiotensin Receptor Blockers (ARBs): Drug Safety Communication - Drug Safety Review Completed. How do chemicals used in rocket fuel ever enter into the pill manufacturing process? 2.1 General Considerations. The .gov means it’s official.Federal government websites often end in .gov or .mil. An official website of the United States government, : Jun 2, 2011. The recall of dozens of lots of valsartan-, losartan-, and irbesartan-containing drugs has become the FDA’s largest class I recalls in its history. FDA has determined the recalled ARBs pose an unnecessary risk to patients. Torrent expands its voluntary recall of losartan Update [1/3/2019] Torrent Pharmaceuticals is expanding its voluntary recall to include eight additional lots of losartan potassium tablets, for a total of 10 lots. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. A Class 2 Medicines recall has been announced by the MHRA with Actavis Group recalling three batches of Irbesartan due to possible contamination with N-nitrosodiethylamine (NDEA). The voluntary recall affects the 75 mg, 150 mg, and 300 mg doses of irbesartan made by Sciegen and labeled as Westminster Pharmaceuticals and Golden State Medical Supply (GSMS), two companies who have partnered with Sciegen for the distribution of generic irbesartan. The impurity may cause tumors in various organs, including the liver, intestines, prostate, colon, and … What are valsartan, losartan, and irbesartan? Should I continue taking my medication even if it has been recalled? This is the second recall this year where a cancer-causing agent was found in an ARB heart medication. Top News Videos for irbesartan recall. Be certain to check samples to ensure affected products are not given to patients. Solco Healthcare, a subsidiary of Prinston Pharmaceutical, launched a voluntary recall of one lot of irbesartan and seven lots of irbesartan and hydrochlorothiazide (HCTZ) combination tablets. The side effects of irbesartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much … A recall action is an action taken to resolve a problem with a therapeutic good already supplied in the market for which there are issues or deficiencies in relation to … Prinston Pharmaceuticals has recalled one lot of Irbesartan and seven lots of Irbesartan HCTZ, the company announced in a news release. Laval H7L 3W9 Quebec CANADA Marketing Authorization Holder Pro Doc Ltd. 2925 Industrial Blvd. Because not … It’s a drug called an angiotensin receptor blocker (ARB). If you have medication samples from these companies, quarantine the products, and do not provide them to patients. The warning comes as a growing list of the drugs containing valsartan, losartan and irbesartan have been recalled from the market for containing an impurity that presents a cancer risk. If the lot number is on the medication bottle, it is usually imprinted on the label and is normally found next to the expiration date. Additional information including a list of affected lots can be found at https://www.fda.gov/drugs/drug-safety-and-availability/recalls-angiotensin-ii-receptor-blockers-arbs … Medications containing only amlodipine or hydrochlorothiazide (HCTZ) are not being recalled. Prinston Pharmaceuticals has recalled one lot of Irbesartan and seven lots of Irbesartan HCTZ, the company announced in a news release. Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan. In October 2018, the FDA recalled Irbesartan after finding the probable human carcinogen N-nitrosodiethylamine (NDEA) had contaminated the drug. Up-to-date information on the specific lots of Valsartan, Losartan, and Irbesartan that are affected can be found on the recall list maintained by the FDA. This recall affects about 1% of the irbesartan drug products in the US market, according to the FDA. FDA has posted a list of currently available ARBs and the status of our assessment of those medications. Nitrosamine impurities, including N-Nitrosodimethylamine (NDMA), and N-Nitrosodiethylamine (NDEA), are probable human carcinogens (a substance that could cause cancer), and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) is a potential human carcinogen. In October 2018, the FDA recalled Irbesartan after finding the probable human carcinogen N-nitrosodiethylamine (NDEA) had contaminated the drug. What should I know as a health care professional? irbesartan recall list: solco irbesartan recall: irbesartan recall 2018: irbesartan side effects: fda irbesartan recall list: fda irbesartan recall: 12 3 4. Consumers and health professionals are encouraged to report problems with medicines or vaccines. 00:33. Search the full ARB recalls list FDA has worked with manufacturers to swiftly remove … The recall affects 22 batches of irbesartan manufactured by Aurobindo Pharma, which were then used to make 27 lots of Sciegen Pharmaceuticals irbesartan. KGUN - … The impurity may cause tumors in various organs, including the liver, intestines, prostate, colon, and stomach. Essaar Inc. Issues Voluntary Nationwide Recall of Rubbing Alcohol Contaminated with Methanol. One lot of irbesartan and 7 lots of irbesartan and hydrochlorothiazide (HCTZ) combination tablets distributed by Solco Healthcare, a Prinston Pharmaceutical subsidiary are affected, according to a statement from the administration. The irbesartan active pharmaceutical ingredient (API) in the recalled lots is manufactured by Teva API India Ltd. An API is the active ingredient in a drug that produces an effect on the body. Where do I find the lot number of my medication? Sandoz Irbesartan/HCT 300/12.5 mg (three batches) - December 2018; Sandoz Irbesartan 150 mg (one batch) - January 2019. The irbesartan tablets (USP 75 mg, 150 mg and 300 mg) subject to recall are labeled as Westminster Pharmaceuticals and Golden State Medical Supply, Inc. and are packed in 30-count and 90-count bottles. Companies Recalling Firm Pro Doc Ltd. 2925 Industrial Blvd. Because ARBs treat serious medical conditions, continue taking your current medicine until a doctor or pharmacist gives you a replacement or a different treatment option. Prinston Pharmaceuticals has recalled one lot of Irbesartan and seven lots of Irbesartan HCTZ, the company announced in a news release. Learn more about the NDC. Where do I find the manufacturer or repackager name and National Drug Code (NDC) of my medication? In July 2018, the FDA announced a voluntary recall of several drugs containing valsartan, used to treat high blood pressure and heart failure, because of contamination with an impurity, the potentially cancer-causing chemical N-nitrosodimethylamine, or NDMA. This time, SciGen is recalling certain lots of irbesartan. Teva Pharmaceuticals USA Inc., labeled as Actavis Pharma, Inc. Teva Pharmaceuticals USA Inc., labeled as Major Pharmaceuticals, Amlodipine/Valsartan/Hydrochlorothiazide (HCTZ) 5mg/160mg/25mg Tablet, Torrent Pharmaceuticals Limited, labeled as Major Pharmaceuticals. Nitrosamines are known environmental contaminants and found in water and foods, including meats, dairy products and vegetables. The FDA said in a March 22 posting on its website that it has updated the list of valsartan medicines under recall to incorporate additional repackagers of … Beginning in mid-2018, FDA found that several angiotensin II receptor blocker (ARB) medicines contained nitrosamine impurities and have been recalled because they do not meet FDA's safety standards. Lupin and Westminster did not provide a reason for the shortage. Samples can also be affected and part of the recall. Prinston said the following irbesartan and irbesartan hydrochlorothiazide tablets have been recalled: • Irbesartan, 300 mg, 90 count, lot number 331B18009, expires February 2021 • Irbesartan HCTZ, 300 mg/12.5 mg, 30 count, lot number 327A18001, expires March 2021 • Irbesartan … The FDA is alerting patients of a recent recall of irbesartan, an angiotensin II receptor blocker (ARB) used to treat heart disease. Review a list of the recalled lot numbers here. The FDA is alerting patients and health care professionals to a voluntary recall of certain angiotensin II receptor blockers (ARBs). Update [1/3/2019] Torrent Pharmaceuticals is expanding its voluntary recall to include eight additional lots of losartan potassium tablets, for a total of 10 lots. Download and complete the appropriate form, then submit it via fax at. The .gov means it’s official.Federal government websites often end in .gov or .mil. Find out which specific blood pressure medications are affected by the recall, Search the full list of recalled angiotensin II receptor blockers (ARB) below by company, medicine, National Drug Code (NDC), lot number, or expiration date, FDA's Assessment of Currently Marketed ARBs. However, … Drug Safety and Availability, Recalls, Market Withdrawals and Safety Alerts, Information about Nitrosamine Impurities in Medications, Medication Errors Related to CDER-Regulated Drug Products, Postmarket Drug Safety Information for Patients and Providers, Risk Evaluation and Mitigation Strategies | REMS, Multistate outbreak of fungal meningitis and other infections, Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan, A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco), Valsartan/Hydrochlorothiazide (HCTZ) 160mg/12.5mg Tablet, Valsartan/Hydrochlorothiazide (HCTZ) 320mg/25mg Tablet, Valsartan/Hydrochlorothiazide (HCTZ) 80mg/12.5mg Tablet, Valsartan/Hydrochlorothiazide (HCTZ) 160mg/25mg Tablet, Valsartan/Hydrochlorothiazide (HCTZ) 320mg/12.5mg Tablet, Losartan/Hydrochlorothiazide (HCTZ) 50mg/12.5mg Tablet, Losartan/Hydrochlorothiazide (HCTZ) 100mg/12.5mg Tablet, Golden State Medical Supply (Teva Pharamceuticals USA, Inc.), H J Harkins Company Inc dba Pharma Pac (Camber), H J Harkins Company Inc. dba Pharma Pac (Prinston/Solco). irbesartan recall list: irbesartan recall solco: irbesartan recall 2018: irbesartan side effects: fda irbesartan recall list: fda irbesartan recall: 12 3. Hikma is not actively marketing irbesartan tablets. Find out which specific blood pressure medications are affected by the recall Health Canada issued a notice about the Mylan-Valsartan recall on November 28, 2018, and has updated the list of recalled and NOT recalled valsartan products below. The October 2018 recall affects multiple batches of the drug, supplied by Aurobindo Pharam Limited, headquartered in India. Remember, not all ARBs are being recalled, and not all lots of valsartan, irbesartan, and losartan are affected and being recalled. Laval H7L 3W9 Quebec CANADA Marketing Authorization Holder Pro Doc Ltd. 2925 Industrial Blvd. The medications are … Which ARB medications are being recalled? For the latest FDA MedWatch alerts, go here. Talk with your doctor or pharmacist before changing any medicine. Tests showed that the recalled lots, manufactured by SciGen Pharmaceuticals, contain a possible human carcinogen. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. FDA suggests health care professionals check the lists regularly for updates. Macleods Pharmaceuticals became the latest company to recall Losartan blood pressure medication for the presence of NDEA. The expanded recall involves the products listed below and packaged in bottles. Irbesartan USP is a white to off-white crystalline powder with a molecular weight of 428.5. Recent FDA Alert(s) for candesartan Angiotensin Receptor Blockers (ARBs): Drug Safety Communication - Drug Safety Review Completed. Recent FDA Alert(s) for olmesartan Olmesartan: Drug Safety Communication - FDA Review Finds Cardiovascular Risks for Diabetics Not Conclusive. To find out if your medication has been recalled, you need the following information: Following is an example of an ARB medication label to help you identify the information on your medication: Note the manufacturer may be different from the distributor or labeler of your medication. The medications are … 2018 ended in what had become the year’s drug recall … Yes. 00:33. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. Irbesartan 150mg. Some manufacturers are recalling some medications containing amlodipine in combination with valsartan or losartan, and some medications containing hydrochlorothiazide HCTZ in combination with valsartan or losartan are also being recalled. The recalled lot will have “Westminster Pharmaceuticals” and “GSMS Inc.” on the label, according to … Next 27 results. Prinston Pharmaceuticals has recalled one lot of Irbesartan and seven lots of Irbesartan HCTZ, the company announced in a news release. If you are taking any medication containing an ARB, compare the information on your prescription bottle with the recall list to determine if your current medicine has been recalled. Next 34 results. Prinston Pharmaceuticals found unacceptable levels of nitrosodiethylamine, a probable carcinogan, in the medication, recalling seven lots of irbesartan HCTZ tablets and one irbesartan tablets, according to the report. Get current information about recalls of blood pressure medications, FDA's Assessment of Currently Marketed ARBs, An explanation of FDA's ongoing recall of Valsartan, Losartan, and IrbesartanTranscript. If the pharmacist cannot provide this, contact your doctor to discuss other treatment options. Not all valsartan-, losartan-, or irbesartan-containing medications are affected and being recalled. The presence of these nitrosamine impurities in ARB medicines was unexpected. A recall is a voluntary action taken by a company at any time to remove a defective drug product from the market. Before sharing sensitive information, make sure you're on a federal government site. Why are some valsartan, losartan, and irbesartan medicines being recalled? Blood Pressure Medication Recall: Irbesartan. Contact your pharmacist to get this information if you cannot find it or if you have questions about your medication being recalled. All recalls are due to the presence of NDEA. FDA recommends that pharmacists provide a replacement medicine not affected by the recall or prescribers consider other available treatment options for their patient’s medical condition. Irbesartan oral tablet is a prescription medication used to treat high blood pressure and diabetic nephropathy caused by type 2 diabetes. Before sharing sensitive information, make sure you're on a federal government site. The FDA has issued a recall for irbesartan, a hypertension and blood pressure medication, due to contamination with cancer-causing agents. The medications are … Get regular FDA email updates delivered on this topic to your inbox. For a complete list of irbesartan medications under recall, please click here. Irbesartan Recall Lawsuit. Companies Recalling Firm Pro Doc Ltd. 2925 Industrial Blvd. The recalled ScieGen Pharmaceuticals Inc. Irbesartan was labeled as Westminster Pharmaceuticals and Golden State Medical Supply, Inc., a list of the recalled lot numbers is included in the recall. ScieGen’s irbesartan products are labeled as Westminster Pharmaceuticals and Golden State Medical Supply, Inc. (GSMS). The U.S. Food and Drug Administration (FDA) has issued an alert that people taking the blood pressure medication, irbesartan, should contact their doctor immediately as ScieGen Pharmaceuticals Inc. is recalling certain lots of the drug with “Westminster Pharmaceuticals” and “GSMS Inc.” on the label due to possible contamination of a carcinogen used in the production … Our ongoing effort has determined that these impurities may be generated when specific chemicals and reaction conditions are present in the manufacturing process of the drug’s API, and may also result from the reuse of materials, such as solvents. Report any adverse reactions with ARB-containing products, to FDA’s MedWatch program to help the agency better understand the scope of the problem: An official website of the United States government, : It will also be printed on the back of a blister pack. The medications are … The pharmacist may be able to provide you with an unaffected ARB made by another company. The recall is being undertaken following the detection of trace amounts of an impurity found in an active pharmaceutical ingredient made by Zhejiang Huahai Pharmaceuticals. list of ARB medications affected by the recall, list of ARBs that are currently available. 604292. 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. Trace amounts of a carcinogen revealed in testing has forced a drug company to recall irbesartan blood pressure medication, USA Today reported. The FDA has issued a recall for irbesartan, a hypertension and blood pressure medication, due to contamination with cancer-causing agents. For the latest FDA MedWatch alerts, go here. Not all lots of valsartan, irbesartan, and losartan from a manufacturer involved in a recall are affected and being recalled. Read more on ACC.org. This recall is due to trace amounts of N-Nitrosodiethylamine (NDEA) in the losartan active pharmaceutical ingredient (API) … January 4, 2021 -- Essaar Inc. is voluntarily recalling lot 200528303 of Soho Fresh 70% Rubbing Alcohol in 33.81 oz. Lot or serial number. Details of all of the above recalls appear in the TGA's System for Australian Recall Actions database. Jun 2, 2011. Torrent expands its voluntary recall of losartan. FDA Places Zhejiang Huahai Pharmaceuticals on Import Alert (9/28/2018) The side effects of irbesartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much … A Class 2 Medicines recall has been announced by the MHRA with Actavis Group recalling three batches of Irbesartan due to possible contamination with N-nitrosodiethylamine (NDEA). The FDA stresses that people who are on Valsartan should continue to take their medication as directed. Because not all valsartan and irbesartan drugs are involved in the recall, you might be able to switch to a version by another company. The FDA has added 80 lots of Amlodipine Valsartan blood pressure medication to the hypertension drug recall list that continues to grow. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The site is secure. Camber did not provide a reason for the shortage. Some Irbesartan tablets manufactured by ScieGen Pharmaceuticals and labeled as Westminster Pharmaceuticals and Golden State Medical Supply, Inc (GSMS) are impacted by the … 18 January 2019 to 25 January 2019 – Solco Healthcare recalls seven lots of irbesartan-containing products, Torrent Pharmaceuticals’ expands its losartan recall to include an additional six lots (16 in total), and Macleods Pharmaceuticals recalls one lot of losartan potassium/hydrochlorothiazide. FDA has also posted a list of ARBs that are currently available, along with information regarding the status of FDA’s assessment for those medications. 604292. However, not all lots of these medications are affected and being recalled. Irbesartan oral tablet, Alembic, 150 mg, bottle, 90 count, NDC 62332-0042-90; ... Solco and ScieGen were affected by the recall. APIs are used in the manufacturing of finished dosage form drugs (such as pills, capsules or tablets). If you have medicine included in a recall, contact your pharmacist. Valsartan, losartan, irbesartan and other “-sartan” drugs are a class of medicines known as angiotensin II receptor blocker (ARBs) used to treat high blood pressure and heart failure. Not all lots of valsartan, irbesartan, and losartan from a manufacturer involved in a recall are affected and being recalled. Laval H7L 3W9 Quebec CANADA The recall is due to unacceptable amounts of N-Nitrosodiethylamine (NDEA). Top News Videos for irbesartan recall. Lot or serial number. The latest recall joins many others of recent weeks, all of which were made, or include ingredients made, in China or India. Reporting problems. Top News Videos for irbesartan recall. Blood Pressure Medication Recall: Irbesartan. 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