There is currently no warning information available for this product. Drug Recall List Last Updated: November 2020 Drug Recall Details Contact Date Drug Recall Class* Lansoprazole Delayed-Release Orally Disintegrating Tablets 06838277177 Failed Dissolution Specifications If you have questions about this recall, Zydus Pharmaceuticals, 1-877-993-8779. We apologize for any inconvenience. 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. So far, my doctors say I am doing well. 111 0 obj <> endobj For example, a combination of valsartan, amlodipine and hydrochlorothiazide is one product that has been recalled. The recall of Losartan is linked to a possible cancer-causing element known as NMBA. DEAR DR. ROACH: I keep hearing that amlodipine, my blood pressure medicine, has a cancer-causing agent in it. 1. Class 3 Medicines Recall: Accord Healthcare Limited, Amlodipine 10mg Tablets Accord Healthcare Limited is recalling a specific batch of Amlodipine 10mg Tablets as a … Although neither amlodipine nor hydrochlorothiazide are currently under recall on their own, they are when combined with some other medications. Our records indicate that you may have received shipment of the affected lots, which were distributed from December 2019 and January 2020. %PDF-1.7 %���� Recalls and safety alerts are sent out when we have important information to share—meaning you can feel more secure when choosing and using products. The recalled medications include specific “lots” of losartan, irbesartan, valsartan and combination drugs with valsartan. The rep urged that anyone who is taking these medications should call Torrent Pharmaceuticals Limited at 1-888-280-2040. Teva Pharmaceuticals has issued a voluntary recall of its amlodipine/valsartan combination tablets and amlodipine/valsartan/hydrochlorothiazide combination tablets, both used to treat high blood pressure, according to the FDA. Most recalls are limited to a single manufacturer and may not be related to the version of a particular drug you are taking. Want to know more? Class 3 Medicines Recall: Accord Healthcare Limited, Amlodipine 10mg Tablets. Please check your stock immediately against the table above. This relaxes the blood vessels and lowers blood pressure. What are Amlodipine and Valsartan? Losartan side effects and dangers are similar to those of valsartan, including muscle cramps and chronic fatigue.Losartan cancer has been alleged in the losartan drugs which are tainted by NDEA and NDMA. Neither Amlodipine or Hydrochlorothiazide are currently under recall,” the FDA said. Aurobindo Pharma, Lupin recall drugs in US market ... Aurobindo Pharma USA recalls 80 lots of blood pressure drug from America 01 Jan, 2019, 04.57 PM IST. The FDA announced the recall … The affected products are: Amva Denk 10/160 Tablets (Amlodipine 10mg and valsartan 160mg) Amva Denk 5/160 Tablets (Amlodipine 5mg and valsartan 160mg) If the pressure is too low, there is a risk that organs will not get enough blood. Earlier in the day, Aurobindo Pharma added 38 lots of Valsartan and Amlodipine and Valsartan tablets to a recall that started with 80 lots at the end of December. Nationwide Recall of Sodium Polystyrene Sulfonate Suspension, USP (15g/60ml) (NDC 0054-0165-51; Lot 856396A Expiration April 2010, and Lot 856693A ExpirationMay 2010) 7/17/2008 National PBM Alert Amlodipine is used with or without other medications to treat high blood pressure.Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. If you’re taking a blood pressure medication that was recently recalled, do not stop taking it. Amlodipine Latest Breaking News, Pictures, Videos, and Special Reports from The Economic Times. In July 2018, the U.S. Food and Drug Administration (FDA) announced the recall of several generic valsartan drugs. endstream endobj 112 0 obj <>/Metadata 5 0 R/Pages 109 0 R/StructTreeRoot 9 0 R/Type/Catalog/ViewerPreferences 129 0 R>> endobj 113 0 obj <>/MediaBox[0 0 612 792]/Parent 109 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 114 0 obj <>stream A rep at Torrent Pharmaceuticals Limited said that "no adverse events have been reported yet.". It’s important to understand that your blood pressure measurement will vary throughout the day; it’s normal. The Food and Drug Administration has recently recalled a number of blood pressure medications after discovering that they contained potential cancer-causing contaminants. 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. The company has shared that they will take back contaminated medications and provide refunds. 03/2020: 65862-740-30: Amlodipine and Valsartan Tablets USP 10mg /320mg: 30: ... Audi recalls model year 2020 Q3s. Accord Healthcare Limited has informed MHRA they are recalling the batch of Amlodipine 10mg Tablets listed below as a precautionary measure due to out of specification results for tablet description, hardness and average weight obtained 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. -�c?p�R7Q�ԁ�����|/;4��ޮp"DgG�����M��׻��E�� b�'4��b8�{"�=�5 Amlodipine … ... 03/2020 American Health Packaging (Aurobindo) ... Amlodipine/Valsartan 5mg/160mg Tablet If the pressure is too high, there’s a risk that the heart will work too hard. 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. The FDA has initiated the recall of the under-listed Amlodipine/Valsartan Combination Tablets manufactured by Denk-Pharma GmbH & Co. KG due to contamination with a. Amlodipine is also used to relieve chronic stable angina (chest pain) in adults. endstream endobj startxref Update [1/2/2019] FDA is alerting patients and health care professionals to Aurobindo Pharma USA’s voluntary recall of two lots of valsartan tablets, 26 lots of amlodipine and valsartan combination tablets, and 52 lots of valsartan and hydrochlorothiazide (HCTZ) combination tablets due to the amount of N-Nitrosodiethylamine (NDEA) in the valsartan active … The guidance focused on detection and prevention of nitrosamine contamination in medication which is known to to cause cancer. ��e. Update [3/1/2019] AurobindoPharma USA is expanding its voluntary recall to include 38 additional lots of valsartan and amlodipine/valsartan combination tablets. So, if you’re taking one of these medications, reach out to your pharmacist or physician to discuss alternative treatments. It affects the movement of calcium into the cells of the heart and blood vessels. Over the past year, the FDA has recalled multiple blood pressure medications from several manufacturers after discovering potential carcinogens in some batches. The investigation is ongoing and the FDA continues to update the list of medications being recalled here. Get the news you need delivered to you. 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." 2. They work by blocking the production of a natural hormone called angiotensin II, which narrow your arteries, raising blood pressure. These medications are for high blood pressure and fall in a drug class known as angiotensin receptor blockers (ARBs). With that said, here are some things you should know if you’re taking these medications. The recall of the above referenced lots of Caduet® (amlodipine besylate/atorvastatin calcium) Tabletsis being conducted to the Retail Level. 153 0 obj <>stream the FDA demanded that their edicts be implemented as soon as possible. �CA���@���A����� ZRP�2���.U�2͝����-t�8>����#�yu��y��E�cQ��[Q��� 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. 0 If your doctor says your blood pressure is 130/80, the 130 would be systolic and the 80 would be diastolic. Find out which specific blood pressure medications are affected by the recall. A lower blood pressure will increase the supply of blood and oxygen to the heart. 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. Recalls and safety alerts are sent out when we have important information to share—meaning you can feel more secure when choosing and using products. Date modified: 2021-01-20 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. What are Amlodipine and Valsartan? Amlodipine besylate tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. h�b```f``�d`a`P�� Ā B@ �80%ρ�a����0 �C1�v�qs��g1K10ų̢�������`�,Lӷ��30�ކ�����:"�p � x�� Weight Loss Deals for 2021. 128 0 obj <>/Filter/FlateDecode/ID[<69CF5D39AA49C848894B2795C02D98BE>]/Index[111 43]/Info 110 0 R/Length 94/Prev 175370/Root 112 0 R/Size 154/Type/XRef/W[1 3 1]>>stream The recall of Losartan is linked to a possible cancer-causing element known as NMBA. Amlodipine besylate tablets, USP is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: Hypertension . 9/1/2020-The FDA determined guidelines for drug manufacturers concerning nitrosamine contamination in medication. Health Letter, April 2020 Note: Never stop taking a drug that appears on the product recall list without first talking to your doctor or pharmacist. Turn on desktop notifications for breaking stories about interest? ... 2010 - … The power: FDA would also get new authority to recall prescription and over-the-counter drugs under an amendment lawmakers adopted by voice vote. I had ovarian cancer surgery in 2010. �;������a��rޟ��M}T.W��1_�'�$��M�5ߚ�)�Dr���&��X�����$�a�C�ꁛ��.tTw�wU�T�2��9�Ԣ�zY泓�j6�ܽ)�R]�1|+�;Fp�w���Z�7��Gim��v�o�6�v�ƫ����F��� i�h����/utv���`xvv�� :�/�(����Q^8/Z�:FyI3���]�'i�p����T�n��-39IԢ����*j)�)�J�ٚ�� �hd,��=�6� ��������H�5ϥn|��#;G���RH�* o�N#:�Z ?���~�m��C+�A��.���|u��}��^�B-�ت^�o^�?���~��@��z�1� #�@G�* ,i�v��.�M���"���&0����@� �i����LK���� They are asked to consult their physicians or pharmacists before making any changes to their medication regimen. h�bbd```b``�"����A$k�d�f�ɋ`u0)"٧�ٓ@$'�d{"׼��ߎ��U@�_O-Ю Y�=������� � �FN October 14, 2020, The National Agency for Food and Drug Administration and Control has received information from United Kingdom Medicine and Healthcare Products Regulatory Agency (MHRA), of a voluntary recall of one batch of high blood pressure medication, Amlodipine 10mg tablets manufactured by Accord Healthcare Limited. NDMA is a chemical that forms in both industrial and natural processes. While your target blood pressure is often determined by your age and medical conditions, most doctors recommend keeping it around 120/80. Laboratoire Riva's recall was for two lots of its 500-milligram ciprofloxacin. ROACH: I keep hearing that amlodipine, my blood pressure medicine, has a cancer-causing agent in it. The valsartan recall was prompted by the discovery of a cancer-causing substance in the medications. Issued 7 September 2020. 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. Is Amlodipine under recall only if combined with Valsartan? Is Amlodipine under recall only if combined with Valsartan? Amlodipine is a drug used alone or with other drugs to treat high blood pressure. Fda said amlodipine nor Hydrochlorothiazide are currently under recall, ” which means it relaxes blood vessels blood. 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