The study is created by eHealthMe based on reports (from sources including the FDA) of 85,094 people who take Irbesartan and Imdur, and is updated regularly. Ask a Question. Hikma is not actively marketing irbesartan tablets. The review into the presence of impurities in sartans and their potential effects in patients is ongoing. Be certain to check samples to ensure affected products are not given to patients.Report any adverse reactions with ARB-containing products, to The recall is due to unacceptable amounts of N-Nitrosodiethylamine (NDEA) in the irbesartan active pharmaceutical ingredient … The inspection findings included deficiencies in the way the company investigated impurities in its valsartan products and led EU authorities to This latest action means that EU authorities will supervise the manufacture of other Authorities will monitor corrective measures being implemented by the company on a regular basis and increase the frequency of inspections of the site. Lupin and Westminster did not provide a reason for the shortage. Message. Get current information about recalls of blood pressure medicationsAn explanation of FDA's ongoing recall of Valsartan, Losartan, and IrbesartanValsartan, 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.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.Some manufacturers are recalling some medications containing amlodipine 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. It will also be printed on the back of a blister pack.Contact your pharmacist to get this information if you cannot find it or if you have questions about your medication being recalled.Yes. EMA is in the process of making appropriate changes to this website. Contact your pharmacist to get this information if you cannot find it or if you have questions about your medication being recalled.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. In addition, In July 2018, the detection of impurities – N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) – in valsartan from Zhejiang Huahai led to an Both NDMA and NDEA, which have not been found in any of Zheijiang Huahai’s other products, are classified as probable human carcinogens (substances that could cause cancers). Comment. MacLeod's has irbesartan tablets available to contracted customers only. Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, Losartan and Irbesartan. Solco and ScieGen were affected by the recall. Get an alert when a recall is issued. Fetal Toxicity. National authorities in the EU are currently considering whether to recall medicines containing Aurobindo Pharma’s irbesartan from pharmacies as a precaution. Camber has irbesartan tablets available. They work by blocking the action of angiotensin II, a hormone that constricts blood vessels and causes blood pressure to rise.The review of valsartan medicines was triggered by the European Commission on 5 July 2018 under Add Info. We compare the side effects and drug effectiveness of Irbesartan and Imdur. Update [1/18/2019] FDA is alerting patients and health care professionals to a voluntary recall of one lot of irbesartan and seven lots of irbesartan and hydrochlorothiazide (HCTZ) combination tablets distributed by Solco Healthcare LLC, a Prinston Pharmaceutical Inc. subsidiary. Sanofi-Aventis did not provide a reason for the shortage. Add Recall Info. Side Effects & Adverse Reactions. EMA will continue working with national authorities, international partners and EDQM and will provide updates as more … Cancel Post Info. Irbesartan distributed by Solco Healthcare voluntarily recalled. Questions & Answers. An official website of the United States government: Drug Safety and Availability EMA will continue working with national authorities, international partners and EDQM and will provide updates as more information becomes available.The ongoing review is evaluating candesartan, irbesartan, losartan, olmesartan and valsartan, which belong to a class of medicines known as angiotensin-II-receptor antagonists (also known as sartans).The medicines are used to treat patients with hypertension (high blood pressure) and those with heart failure or who have had a recent heart attack.