Prinston Pharmaceuticals has recalled one lot of Irbesartan and seven lots of Irbesartan HCTZ, the company announced in a news release. 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 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. For the latest FDA MedWatch alerts, go here. Laval H7L 3W9 Quebec CANADA Laval H7L 3W9 Quebec CANADA Marketing Authorization Holder Pro Doc Ltd. 2925 Industrial Blvd. 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. Macleods Pharmaceuticals became the latest company to recall Losartan blood pressure medication for the presence of NDEA. 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. 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 … Contact your pharmacist to get this information if you cannot find it or if you have questions about your medication being recalled. The FDA has added 80 lots of Amlodipine Valsartan blood pressure medication to the hypertension drug recall list that continues to grow. For a complete list of irbesartan medications under recall, please click here. 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. Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan. 00:33. 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 … In October 2018, the FDA recalled Irbesartan after finding the probable human carcinogen N-nitrosodiethylamine (NDEA) had contaminated the drug. FDA Recalls Hypertension Drug Irbesartan 2018-11-01 02:10:00 Officials with ScieGen Pharmaceuticals, Inc. are voluntarily recalling listed lots, within expiry, of a type of hypertension medication known as Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms … The .gov means it’s official.Federal government websites often end in .gov or .mil. list of ARB medications affected by the recall, list of ARBs that are currently available. Before sharing sensitive information, make sure you're on a federal government site. The medications are … Not all valsartan-, losartan-, or irbesartan-containing medications are affected and being recalled. Lupin and Westminster did not provide a reason for the shortage. Companies Recalling Firm Pro Doc Ltd. 2925 Industrial Blvd. 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. APIs are used in the manufacturing of finished dosage form drugs (such as pills, capsules or tablets). 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. The site is secure. The presence of these nitrosamine impurities in ARB medicines was unexpected. 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. 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. Not all lots of valsartan, irbesartan, and losartan from a manufacturer involved in a recall are affected and being recalled. Irbesartan USP is a white to off-white crystalline powder with a molecular weight of 428.5. FDA Places Zhejiang Huahai Pharmaceuticals on Import Alert (9/28/2018) The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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. The recalled lot will have “Westminster Pharmaceuticals” and “GSMS Inc.” on the label, according to … The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. The impurity may cause tumors in various organs, including the liver, intestines, prostate, colon, and stomach. 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. A recall is a voluntary action taken by a company at any time to remove a defective drug product from the market. Get regular FDA email updates delivered on this topic to your inbox. 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 … An official website of the United States government: Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and I Find out which specific blood pressure medications are affected by the recall 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. 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. 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. Hikma is not actively marketing irbesartan tablets. irbesartan recall list: solco irbesartan recall: irbesartan recall 2018: irbesartan side effects: fda irbesartan recall list: fda irbesartan recall: 12 3 4. Essaar Inc. Issues Voluntary Nationwide Recall of Rubbing Alcohol Contaminated with Methanol. Irbesartan 150mg. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. Companies Recalling Firm Pro Doc Ltd. 2925 Industrial Blvd. Irbesartan Recall Lawsuit. Consumers and health professionals are encouraged to report problems with medicines or vaccines. 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. The FDA stresses that people who are on Valsartan should continue to take their medication as directed. Recent FDA Alert(s) for candesartan Angiotensin Receptor Blockers (ARBs): Drug Safety Communication - Drug Safety Review Completed. All recalls are due to the presence of NDEA. 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 … 604292. 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. Review a list of the recalled lot numbers here. What are valsartan, losartan, and irbesartan? Read more on ACC.org. Irbesartan oral tablet, Alembic, 150 mg, bottle, 90 count, NDC 62332-0042-90; ... Solco and ScieGen were affected by the recall. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. Recent FDA Alert(s) for olmesartan Olmesartan: Drug Safety Communication - FDA Review Finds Cardiovascular Risks for Diabetics Not Conclusive. Recent FDA Alert(s) for candesartan Angiotensin Receptor Blockers (ARBs): Drug Safety Communication - Drug Safety Review Completed. The FDA has issued a recall for irbesartan, a hypertension and blood pressure medication, due to contamination with cancer-causing agents. 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. Before sharing sensitive information, make sure you're on a federal government site. 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, : The site is secure. The agency also updated the list of irbesartan products under recall. Samples can also be affected and part of the recall. The latest recall joins many others of recent weeks, all of which were made, or include ingredients made, in China or India. Next 29 results. Not all lots of valsartan, irbesartan, and losartan from a manufacturer involved in a recall are affected and being recalled. 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 .gov means it’s official.Federal government websites often end in .gov or .mil. Remember, not all ARBs are being recalled, and not all lots of valsartan, irbesartan, and losartan are affected and being recalled. Details of all of the above recalls appear in the TGA's System for Australian Recall Actions database. FDA has determined the recalled ARBs pose an unnecessary risk to patients. January 4, 2021 -- Essaar Inc. is voluntarily recalling lot 200528303 of Soho Fresh 70% Rubbing Alcohol in 33.81 oz. Torrent expands its voluntary recall of losartan. Search the full ARB recalls list FDA has worked with manufacturers to swiftly remove … The FDA has issued a recall for irbesartan, a hypertension and blood pressure medication, due to contamination with cancer-causing agents. If the pharmacist cannot provide this, contact your doctor to discuss other treatment options. Laval H7L 3W9 Quebec CANADA 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. Irbesartan oral tablet is a prescription medication used to treat high blood pressure and diabetic nephropathy caused by type 2 diabetes. Trace amounts of a carcinogen revealed in testing has forced a drug company to recall irbesartan blood pressure medication, USA Today reported. The October 2018 recall affects multiple batches of the drug, supplied by Aurobindo Pharam Limited, headquartered in India. Jun 2, 2011. 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. 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. Top News Videos for irbesartan recall. Why are some valsartan, losartan, and irbesartan medicines being recalled? See the list of irbesartan products under recall. 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. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. ScieGen’s irbesartan products are labeled as Westminster Pharmaceuticals and Golden State Medical Supply, Inc. (GSMS). 00:33. The medications are … It’s a drug called an angiotensin receptor blocker (ARB). Medications containing only amlodipine or hydrochlorothiazide (HCTZ) are not being recalled. 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. 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. This time, SciGen is recalling certain lots of irbesartan. The FDA is alerting patients and health care professionals to a voluntary recall of certain angiotensin II receptor blockers (ARBs). 604292. Aurobindo Pharma USA … Where do I find the lot number of my medication? 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. If you have medication samples from these companies, quarantine the products, and do not provide them to patients. The medications are … Blood Pressure Medication Recall: Irbesartan. Prinston Pharmaceuticals has recalled one lot of Irbesartan and seven lots of Irbesartan HCTZ, the company announced in a news release. Reporting problems. irbesartan recall list: irbesartan recall solco: irbesartan recall 2018: irbesartan side effects: fda irbesartan recall list: fda irbesartan recall: 12 3. However, … Blood Pressure Medication Recall: Irbesartan. Prinston Pharmaceuticals has recalled one lot of Irbesartan and seven lots of Irbesartan HCTZ, the company announced in a news release. For the latest FDA MedWatch alerts, go here. Blood Pressure Medication Recall: Irbesartan. 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. 2018 ended in what had become the year’s drug recall … Next 34 results. 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 … Be certain to check samples to ensure affected products are not given to patients. 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. 2 years ago. The impurity may cause tumors in various organs, including the liver, intestines, prostate, colon, and … Irbesartan Recall Lawsuit. 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. Because not … Which ARB medications are being recalled? 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 recall affects 22 batches of irbesartan manufactured by Aurobindo Pharma, which were then used to make 27 lots of Sciegen Pharmaceuticals irbesartan. Some Irbesartan tablets manufactured by ScieGen Pharmaceuticals and labeled as Westminster Pharmaceuticals and Golden State Medical Supply, Inc (GSMS) are impacted by the … Next 27 results. 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