��e. 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. 03/2020: 65862-740-30: Amlodipine and Valsartan Tablets USP 10mg /320mg: 30: ... Audi recalls model year 2020 Q3s. ... 03/2020 American Health Packaging (Aurobindo) ... Amlodipine/Valsartan 5mg/160mg Tablet This relaxes the blood vessels and lowers blood pressure. %%EOF ... Amlodipine recall. Amlodipine is a calcium channel blocker. Update [3/1/2019] AurobindoPharma USA is expanding its voluntary recall to include 38 additional lots of valsartan and amlodipine/valsartan combination tablets. -�c?p�R7Q�ԁ�����|/;4��ޮp"DgG�����M��׻��E�� b�'4��b8�{"�=�5 “Similarly, Losartan potassium and Hydrochlorothiazide 100mg/25mg is a recalled product . The company has shared that they will take back contaminated medications and provide refunds. Find out which specific blood pressure medications are affected by the recall. Most recalls are limited to a single manufacturer and may not be related to the version of a particular drug you are taking. If the pressure is too high, there’s a risk that the heart will work too hard. ", (MORE: How to lower your blood pressure without medication), (MORE: Here's why you need to start asking your doctor to check your blood pressure twice), (MORE: Holiday shopping: The best toys for kids make use of their imaginations, not a screen), (MORE: Obstructive sleep apnea linked to heart disease, especially in women), (MORE: 'Friend after friend was dying': HIV survivors look back at past 30 years of AIDS in the US). 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." Amlodipine … ... Amlodipine not associated with recalls National News. 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. They work by blocking the production of a natural hormone called angiotensin II, which narrow your arteries, raising blood pressure. A lower blood pressure will increase the supply of blood and oxygen to the heart. 0 Class 3 Medicines Recall: Accord Healthcare Limited, Amlodipine 10mg Tablets. 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. Want to know more? Other lots of losartan as well as other drugs from several manufacturers have been recalled voluntarily in recent months as well due to contamination from other chemicals. 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 power: FDA would also get new authority to recall prescription and over-the-counter drugs under an amendment lawmakers adopted by voice vote. The guidance focused on detection and prevention of nitrosamine contamination in medication which is known to to cause cancer. For example, a combination of valsartan, amlodipine and hydrochlorothiazide is one product that has been recalled. The recall of the above referenced lots of Caduet® (amlodipine besylate/atorvastatin calcium) Tabletsis being conducted to the Retail Level. Tulsie N. Patel, MD is a chief resident in psychiatry from Dallas, TX, working with the ABC News Medical Unit. Often, it can be controlled with a combination of lifestyle modifications and a variety of medications. h�b```f``�d`a`P�� Ā B@ �80%ρ�a����0 �C1�v�qs��g1K10ų̢�������`�,Lӷ��30�ކ�����:"�p � x�� The recalled medications include specific “lots” of losartan, irbesartan, valsartan and combination drugs with valsartan. These medications are for high blood pressure and fall in a drug class known as angiotensin receptor blockers (ARBs). 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 also used to relieve chronic stable angina (chest pain) in adults. Blood pressure is a measure of how efficiently our hearts push blood through our arteries. Is Amlodipine under recall only if combined with Valsartan? 153 0 obj <>stream the FDA demanded that their edicts be implemented as soon as possible. Please check your stock immediately against the table above. 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. 1. Sanis Health's recalled products were certain doses and lot numbers of lamotrigine and amlodipine. 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. 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 %���� 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. Blood pressure measurements are actually two measurements: systolic, which is when the heart squeezes blood through the body, and diastolic, which is the pressure of blood when the heart is at rest. So, if you’re taking one of these medications, reach out to your pharmacist or physician to discuss alternative treatments. 2. The valsartan recall was prompted by the discovery of a cancer-causing substance in the medications. The Food and Drug Administration has recently recalled a number of blood pressure medications after discovering that they contained potential cancer-causing contaminants. Amlodipine Latest Breaking News, Pictures, Videos, and Special Reports from The Economic Times. 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 … Torrent Pharmaceuticals Limited said it suspects that contamination is related to manufacturing at a specific site and is therefore working on "manufacturing and distributing new pills without the contaminant.". I had ovarian cancer surgery in 2010. The affected products are: Amva Denk 10/160 Tablets (Amlodipine 10mg and valsartan 160mg) Amva Denk 5/160 Tablets (Amlodipine 5mg and valsartan 160mg) Weight Loss Deals for 2021. 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 We apologize for any inconvenience. What are Amlodipine and Valsartan? The FDA announced the recall … Amlodipine is a drug used alone or with other drugs to treat high blood pressure. h�bbd```b``�"����A$k�d�f�ɋ`u0)"٧�ٓ@$'�d{"׼��ߎ��U@�_O-Ю Y�=������� � �FN Laboratoire Riva's recall was for two lots of its 500-milligram ciprofloxacin. Teva Pharmaceuticals USA has issued a voluntary nationwide recall of "all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets. The Food and Drug Administration announced Aurobindo Pharma USA, Inc. is voluntarily recalling 80 lots of Amlodipine Valsartan Tablets, Valsartan HCTZ Tablets, and Valsartan Tablets. It affects the movement of calcium into the cells of the heart and blood vessels. The Sandoz Inc. recall involved 100 milligram/25 milligram Losartan tablets with the lot number JB8912 and expiration date of June 2020. While your target blood pressure is often determined by your age and medical conditions, most doctors recommend keeping it around 120/80. The recall of Losartan is linked to a possible cancer-causing element known as NMBA. 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. Get the news you need delivered to you. If you’re taking a blood pressure medication that was recently recalled, do not stop taking it. High blood pressure, which is also called hypertension, causes stress on your heart and can contribute to heart disease. endstream endobj startxref 1. It’s believed they became contaminated during the manufacturing process. Date modified: 2021-01-20 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. 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. �;������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���� 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. DEAR DR. ROACH: I keep hearing that amlodipine, my blood pressure medicine, has a cancer-causing agent in it. Although neither amlodipine nor hydrochlorothiazide are currently under recall on their own, they are when combined with some other medications. 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. What are Amlodipine and Valsartan? : To date, none of the manufacturers have received any reports of people who use these medications becoming ill. High blood pressure is one of the most common medical conditions. 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. A rep at Torrent Pharmaceuticals Limited said that "no adverse events have been reported yet.". When a product is recalled, or an advisory or alert is issued, it means our surveillance tools are working. �CA���@���A����� ZRP�2���.U�2͝����-t�8>����#�yu��y��E�cQ��[Q��� It works as a “calcium channel blocker,” which means it relaxes blood vessels so blood can flow more easily. Amlodipine besylate tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. 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 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. Some of the recalled lots contain a combination of medications. Issued 7 September 2020. The FDA says that “the risk of harm to someone’s health may be higher if one of these medications is stopped immediately without any alternative treatment.”. The investigation is ongoing and the FDA continues to update the list of medications being recalled here. 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. 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. 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. 24/7 coverage of breaking news and live events. The rep urged that anyone who is taking these medications should call Torrent Pharmaceuticals Limited at 1-888-280-2040. Class 3 Medicines Recall: Accord Healthcare Limited, Amlodipine 10mg Tablets Accord Healthcare Limited is recalling a specific batch of Amlodipine 10mg Tablets as a … They are asked to consult their physicians or pharmacists before making any changes to their medication regimen. Biden takes step to require federal contractors pay $15 minimum wage, Secret Service protection extended to Trump family members, ex-staffers, Sen. Bernie Sanders becomes unlikely inauguration fashion star, Capitol riot latest: Lawyer who kicked down Nancy Pelosi's door denied bail. Turn on desktop notifications for breaking stories about interest? [g��^���f�� It’s important to understand that your blood pressure measurement will vary throughout the day; it’s normal. ... 2010 - … Neither Amlodipine or Hydrochlorothiazide are currently under recall,” the FDA said. 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. In July 2018, the U.S. Food and Drug Administration (FDA) announced the recall of several generic valsartan drugs. 111 0 obj <> endobj The recall of Losartan is linked to a possible cancer-causing element known as NMBA. There is currently no warning information available for this product. ROACH: I keep hearing that amlodipine, my blood pressure medicine, has a cancer-causing agent in it. Is Amlodipine under recall only if combined with Valsartan? Amlodipine Blogs, Comments and Archive News on Economictimes.com ... 04 Jun, 2020, 08.27 AM IST. 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 . The affected product was … h�ėko�F���|�Uy�i�D $�6i�Ц��Np�%�x����=c�����]!3��̙w�sf,d`� ř4(3�dA�PLq�R3%�n���e�Q���g-�BSnЍF�VB㩡�4̼���II�Z3��:0%�WÙ2�nS���H�8ž|I��j1�_��ø�g��ߊ^/N���j��ϒ�ˢHΞ���:���!gb�b�gb�,Z�Wżf>�������ԏLs���EQNkf�J�Ecv"�MF�|���ɨ�ק��szb����.Zd��u�T$��X]��TO���۫q|u�t�9O.�|V>��S̍'_�|RΧL��*n��:����?Р��A^-�E]-�? If your doctor says your blood pressure is 130/80, the 130 would be systolic and the 80 would be diastolic. Over the past year, the FDA has recalled multiple blood pressure medications from several manufacturers after discovering potential carcinogens in some batches. December 23, 2020 AvKARE Issues Voluntary Nationwide Recall of Sildenafil 100mg Tablets and Trazodone 100mg Tablets Due to Product Mix-Up December 9, 2020 -- AvKARE, Pulaski, TN is voluntarily recalling one lot of Sildenafil 100 mg tablets and one lot of Trazodone 100mg tablets to the consumer... December 9, 2020 If the pressure is too low, there is a risk that organs will not get enough blood. 9/1/2020-The FDA determined guidelines for drug manufacturers concerning nitrosamine contamination in medication. 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. With that said, here are some things you should know if you’re taking these medications. 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 So far, my doctors say I am doing well. 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