Recent FDA Alert(s) for candesartan Angiotensin Receptor Blockers (ARBs): Drug Safety Communication - Drug Safety Review Completed. It is a nonpolar compound with a partition coefficient (octanol/water) of 10.1 at pH of 7.4. 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 … Where do I find the lot number of my medication? The FDA has issued a recall for irbesartan, a hypertension and blood pressure medication, due to contamination with cancer-causing agents. If you have medicine included in a recall, contact your pharmacist. The site is secure. The FDA stresses that people who are on Valsartan should continue to take their medication as directed. 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. The medications are … Read more on ACC.org. 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. Companies Recalling Firm Pro Doc Ltd. 2925 Industrial Blvd. Find out which specific blood pressure medications are affected by the recall Next 27 results. Laval H7L 3W9 Quebec CANADA Marketing Authorization Holder Pro Doc Ltd. 2925 Industrial Blvd. If the pharmacist cannot provide this, contact your doctor to discuss other treatment options. FDA suggests health care professionals check the lists regularly for updates. The impurity may cause tumors in various organs, including the liver, intestines, prostate, colon, and stomach. 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 medications are … 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. Not all lots of valsartan, irbesartan, and losartan from a manufacturer involved in a recall are affected and being recalled. Which ARB medications are being recalled? 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. 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 … Reporting problems. 604292. Because not … 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. Should I continue taking my medication even if it has been recalled? Torrent expands its voluntary recall of losartan. Remember, not all ARBs are being recalled, and not all lots of valsartan, irbesartan, and losartan are affected and being recalled. 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, : Not all valsartan, losartan, and irbesartan-containing medications are affected and being recalled. Companies Recalling Firm Pro Doc Ltd. 2925 Industrial Blvd. 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. However, … 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. NDEA and NDMA can be unintentionally introduced into manufacturing through certain chemical reactions. Samples can also be affected and part of the recall. 00:33. Not all valsartan-, losartan-, or irbesartan-containing medications are affected and being recalled. You can find a comprehensive list of all recalled … Get regular FDA email updates delivered on this topic to your inbox. Irbesartan 150mg. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. 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. 2018 ended in what had become the year’s drug recall … Essaar Inc. Issues Voluntary Nationwide Recall of Rubbing Alcohol Contaminated with Methanol. FDA has determined the recalled ARBs pose an unnecessary risk to patients. Lupin and Westminster did not provide a reason for the shortage. Blood Pressure Medication Recall: Irbesartan. 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. Consumers and health professionals are encouraged to report problems with medicines or vaccines. 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. Irbesartan oral tablet, Alembic, 150 mg, bottle, 90 count, NDC 62332-0042-90; ... Solco and ScieGen were affected by the recall. FDA has posted a list of currently available ARBs and the status of our assessment of those medications. 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. Sandoz Irbesartan/HCT 300/12.5 mg (three batches) - December 2018; Sandoz Irbesartan 150 mg (one batch) - January 2019. Not all lots of valsartan, irbesartan, and losartan from a manufacturer involved in a recall are affected and being recalled. 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. The .gov means it’s official.Federal government websites often end in .gov or .mil. 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. Blood Pressure Medication Recall: Irbesartan. Talk with your doctor or pharmacist before changing any medicine. 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). 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 … 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. The agency also updated the list of irbesartan products under recall. Before sharing sensitive information, make sure you're on a federal government site. 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. An official website of the United States government: Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and I Next 29 results. KGUN - … Trace amounts of a carcinogen revealed in testing has forced a drug company to recall irbesartan blood pressure medication, USA Today reported. Laval H7L 3W9 Quebec CANADA Marketing Authorization Holder Pro Doc Ltd. 2925 Industrial Blvd. Learn more about the NDC. The FDA is alerting patients of a recent recall of irbesartan, an angiotensin II receptor blocker (ARB) used to treat heart disease. January 4, 2021 -- Essaar Inc. is voluntarily recalling lot 200528303 of Soho Fresh 70% Rubbing Alcohol in 33.81 oz. 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. What are valsartan, losartan, and irbesartan? For a complete list of irbesartan medications under recall, please click here. 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 … This time, SciGen is recalling certain lots of irbesartan. 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. irbesartan recall list: irbesartan recall solco: irbesartan recall 2018: irbesartan side effects: fda irbesartan recall list: fda irbesartan recall: 12 3. Laval H7L 3W9 Quebec CANADA Jun 2, 2011. Tests showed that the recalled lots, manufactured by SciGen Pharmaceuticals, contain a possible human carcinogen. APIs are used in the manufacturing of finished dosage form drugs (such as pills, capsules or tablets). The agency also updated the list of irbesartan products under recall. 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