5 mg/ 20 mg Amlodipine Besylate, Benazepril HCl capsules, 100-count and 500-count bottles. MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Find out why more and more private practices are turning to MedPro Disposal. These medications are being recalled due to the presence of N-Nitrosodiethylamine (NDEA) or N-Nitrosodimethylamine (NDMA). Inadequate investigation of customer complaints by firm. 4.16 million bottles, Novartis Pharmaceuticals. Serious side effects of Amlodipine may include irregular heartbeat, increased chest pain, and swelling in the ankles or feet. Patients using them are advised to seek medical assistance in transferring to … See the full list of all Amlodipine recalls for 2012 through 2017 below. The generic drug company Mylan Pharmaceuticals recalled 104 lots of three medications: valsartan tablets, combination tablets with the drugs valsartan and amlodipine… How does Amlodipine work? Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Reason: Label Mixup: May be mislabeled as Cyanocobalamin. Nov. 27, 2018 -- Two more valsartan blood pressure drugs have been recalled because of impurities in its key ingredient. Manufacturer: Dr. Reddy’s Laboratories Limited. In each case, a recalled drug was contaminated with N-nitrosodimethylamine (NDMA), N-nitrosodiethylamine (NDEA) or N-Nitroso N-Methyl 4 … 10 mg Amlodipine Besylate tablets USP, 1,000-count bottles. 10 mg Amlodipine Besylate tablets, USP, 30 tablets. Recent FDA Alert(s) for amlodipine Warfarin Sodium Tablets (Jantoven), 3mg: Recall - Mislabeled Bottles Containing Higher Dosage. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. The primary risk of substituting 10mg warfarin for 3mg warfarin is overdosing more than 3 times the labeled amount which leads to excessive anticoagulation that could be expected to result in life-threatening hemorrhage in patients. 10 mg Amlodipine Besylate tablets in 25-count, 100-count, and 300-count cartons. Amlodipine tablets manufactured by the company that was registered by the Agency has no such inscription. 5 mg/ 20 mg Amlodipine Besylate, Atorvastatin Calcium tablets, 30-count and 90-count bottles. Lot # 2003156, 2003157, 2003155, 3043491. 10 mg/ 20 mg Amlodipine Besylate, Atorvastatin Calcium tablets, 30-count and 90-count bottles. For example, a 2014 Amlodipine recall from Aidapak Services involved 180 tablets. It’s used in the treatment of conditions due to coronary artery disease, including angina. 2013 Amlodipine recall: Approx. In addition, the 3mg tablet is imprinted with the letters WRF, a line, and the number 3 below the line. Our real-world studies have been referenced on … Expansion of Recall: Affected Products Include Amantadine, Amlodipine, Androxy, Baclofen, Bethanechol, Jantoven and Oxybutynin, We comply with the HONcode standard for trustworthy health information -, Amlodipine Suspension Consumer Information. The next biggest was 2013’s Walmart recall, affecting over 484,000 bottles. Varying amounts of Amlodipine, a pharmaceutical ingredient. 10 mg/ 160 mg Exforge (Amlodipine and Valsartan), 7 tablets per bottle. When treating high blood pressure, Amlodipine works by relaxing the blood vessels, allowing blood to pass through them more easily. 2.5 mg Amlodipine Besylate tablets, USP, 90-count and 500-count bottles. 2013 Amlodipine recall: Approx. There is another potentially large Amlodipine recall from Health Innovations Pharmacy that the FDA lists only as “all lots.” It’s impossible to judge the true size of that recall from FDA data. No immediate danger from FDA violations. Class II Recall. For a comprehensive list, scroll down. 5 mg/ 160 mg/ 25 mg Exforge HCT (Amlodipine, Valsartan, Hydrochlorothiazide), 7 tablets per bottle. You may need to use blood pressure medicine for the rest of your life. Varying amounts of Amlodipine Besylate, a pharmaceutical ingredient. 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 . 4.16 million bottles, Novartis Pharmaceuticals. The affected businesses for the nine major recalls are Lupin, Mylan, Dr. Reddy’s, Wockhardt, American Health Packaging, Novartis, and Walmart. ISSUE: Upsher-Smith Laboratories and FDA notified healthcare professionals of the recall of one lot of Jantoven Warfarin Sodium, USP, 3mg Tablets, an anticoagulant, after a single bottle labeled as Jantoven Warfarin Sodium, USP, 3mg Tablets was found to contain tablets at a higher 10mg strength. Product Manufacturer: Ecomed Pharma Ltd. 4.9/5 (27 Views . Is lisinopril being recalled? 484,000 bottles, Walmart. Why are the drugs being recalled? Lot # F0102, F0115, F0116, F0105, F0109, F0111, F0112, F0121, F0122, F0125A, F0125W1, F0137, F0139, F0140, F0141, F0142, F0144. have risen 18% in the past nine months. Lot # F0131, F0138, F0137, F0139, F0140, F0141, F0142, F0142A, F0145, F0150, F0157, F0158, F0159, F0160, F0163, F0165, F0184. They derived from various companies, including Novartis Pharmaceuticals, Walmart, Mylan Pharmaceuticals, Wockhardt USA, and Dr. Reddy’s Laboratories. 2016 Amlodipine recall: Approx. There has been nine major Amlodipine recalls since 2012 and seven minor ones. They’re bundled here by company and year. While you’re looking into Amlodipine recall data, consider looking into your medical waste disposal spending too. 2.5 mg Amlodipine Besylate tablets, USP, 90-count bottles. There are 49 total recalls of Amlodipine through 2017. High blood pressure often has no symptoms. 55,000 bottles, Lupin Pharmaceuticals. 10 mg/ 40 mg Amlodipine Besylate, Benazepril HCl capsules, 100-count bottles. The reverse side of the 10mg tablet carries the number 832. Class III Recall. Amlodipine is a high blood pressure drug called a. . To find out why more and more practices choose MedPro Waste Disposal, see this handy savings calculator. Audience: Pharmacy, Family Practice, Consumer [UPDATED 02/21/2011] Expansion of Recall: Affected Products Include Amantadine, Amlodipine, Androxy, Baclofen, Bethanechol, Jantoven and Oxybutynin 2.5 mg Amlodipine Besylate tablets in 100-count and 30-count cartons. We study 37,043 people who take Amlodipine besylate or have Radiation recall syndrome. have risen 18% in the past nine months. Nine of the recalls were relatively small. BACKGROUND: The recalled lot is numbered as #284081, with an expiration date of September 2012. 2.5 mg/ 40 mg Amlodipine Besylate, Atorvastatin Calcium tablets, 30-count bottles. Below is a bird’s eye view of all Amlodipine recalls so far. 5 mg/ 320 mg Exforge (Amlodipine and Valsartan), 7 tablets per bottle. 10 mg/ 20 mg Amlodipine Besylate, Benazepril HCl capsules, 100-count and 500-count bottles. Patients taking Amlodipine / Valsartan combination tablets or Amlodipine / Valsartan / Hydrochlorothiazide combination tablets are advised to continue taking their medication and to contact their pharmacist or physician for advice on alternative treatment. Lot # 3038339, 3043618, 3041862, 3044258, 2120031, 2120067, 3035787, 3035834, 3035835, 3037125, 3037126, 3037127, 3037511, 3037512, 3037513, 3038113, 3038114, 3038115, 3038116, 3039641, 3039642, 3039643, 3039974, 3040567, 3040977, 3041253, 3041800, 3041801, 3042446, 3042624, 3043015, 3043401, 3043466, 3044590, 09/14 3044591, 3045063, 3045064. Disclosure: the images on this page are for illustration only and don’t necessarily reflect recalled products. It works by dilating the blood vessels to improve blood flow. There have been nine major Amlodipine recalls since 2012 and seven minor ones. The reverse side of the 3mg tablet carries the number 832. It also shows smaller recalls below 20,000 bottles each. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Lot # F0060, F0028A, F0061, F0062, F0033A, F0037A. 5 mg Amlodipine Besylate tablets, USP, 90-count and 500-count bottles. There are actually 49 FDA recall orders for the popular generic, but that’s because each major recall is made up of several orders each. 2016 Amlodipine recall: Approx. Asked By: Miledys Frere | Last Updated: 19th January, 2020. Lot # DM11421, DM12956, DM12957, DM12963, DM13242, DM13243, DM13251, DM13260, DN10138, DM11035, DM11088, DM11389, DM11393, DM11394, DM12632, DM12633, DM12650, DM12651, DM12667, DM12964, DM13086, DM13155, DM13156, DM13157, DM13158, DM13184, DM13206, DM13207, DM13266, DM13267, DM13268, DM13283, DM13325, DN10058, DN10059, DN10060, DN10061, DN10062, DN10307, DN10308, DN10324, DN10346, DN10809, DN10810, DN10840, DN10877, DN10878, DN10904, DN10905, DN10921, DN10942, DN10943, DN10972. 2013 Amlodipine recall: Approx. A medical practice or clinic can never recall money wasted on overpriced waste disposal. Lot # F0048A, F0056A, F0084, F0085, F0059A, F0088, F0086, F0087, F0061A, F0063W1, F0070A, F0082A. Reason: Possible penicillin cross-contamination. 299,000 bottles, Wockhardt USA. Lot # 3036490, 3036491, 3036492, 3039874 3036493, 3036494, 3039872, 3039873, 3041476, 3041477, 3044555, 3044683. The recall you have heard about most recently is for the combination products Amlodipine/Valsartan and Amlodipine/Valsartan/Hydrochlorothiazide manufactured by Teva. Non-immediate risk of death or severe injury. There are actually 49 FDA recall orders for the popular generic, but that’s because each major recall is made up of several orders each. Amlodipine causes these muscle cells to relax, which allows your arteries to relax and get wider. That recall started with a labeling mixup. 2013 Amlodipine recall: Approx. Amlodipine besylate is the besylate salt of amlodipine, a long-acting calcium channel blocker.Amlodipine besylate is chemically described as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl] 4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5 pyridinedicarboxylate, monobenzenesulphonate.Its molecular formula is C20H25ClN2O5•C6H6O3S and its structural formula is: Amlodipine besylate is a white crystalline powder with a molecular weight of 567.1. To see just how much you could save, check out this handy savings calculator. 2.5 mg/ 20 mg Amlodipine Besylate, Atorvastatin Calcium tablets, 30-count bottles. Teva Pharmaceuticals USA has issued a voluntary nationwide recall of "all lots of Amlodipine / Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets." 5 mg/ 10 mg Amlodipine Besylate, Atorvastatin Calcium tablets, 30-count and 90-count bottles. 5 mg Amlodipine Besylate tablets in 25-count, 30-count, 100-count, and 300-count cartons. RECOMMENDATION: The two Jantoven tablets (see photo at link below) can be readily identified by color: the 3mg tablet is tan and the 10mg tablet is white. 5 mg/ 40 mg Amlodipine Besylate, Atorvastatin Calcium tablets, 30-count and 90-count bottles. This recall … 5 mg/ 20 mg Amlodipine Besylate and Benazepril Hydrochloride, 500 capsules. Category: medical health heart and cardiovascular diseases. 10 mg/ 80 mg Amlodipine Besylate, Atorvastatin Calcium tablets, 30-count bottles. Notification of the recall of these combination products was posted by Drugs.com immediately upon receipt of the recall issued by the … 14 of the 49 FDA recall orders below are Class III. 459,000 bottles, Mylan Pharmaceuticals. Lot # 3039792, 3037880, 3043938, 3036811, 3037514, 3039975, 3042583. 2 More Blood-Pressure Meds Recalled Over Cancer Risk ... valsartan, and amlodipine. The product lot was distributed to wholesalers, retail chains and independent pharmacies throughout the United States. 23,000 bottles, American Health Pharmacy. The biggest recall by far was a 2013 event from Novartis Pharmaceuticals that affected nearly 4.2 million bottles. 484,000 bottles, Walmart. At press time, the FDA had not yet classified the recall. This drug has a much rockier recall history than most of the other most common generics. Lot # 2003159, 2003160, 2003161, 3043492 2003158, 2003159, 3043492. Audience: Pharmacy, Family Practice, Consumer, [UPDATED 02/21/2011] Expansion of Recall: Affected Products Include Amantadine, Amlodipine, Androxy, Baclofen, Bethanechol, Jantoven and Oxybutynin. Several of the recalls were very large, spanning multiple FDA recall orders each. Available for Android and iOS devices. January 2, 2019 / 1:54 PM / CBS News FDA expands recall on blood pressure drug . No report of Radiation recall syndrome is found in people who take Amlodipine besylate. Reason: One lot contained oversized tablets. This includes some combination tablets which contain valsartan and amlodipine or valsartan, amlodipine, and hydrochlorothiazide. Manufacturer: InvaGen Pharmaceuticals, Inc. Reason: Incorrect declared strength on label. Find all the resources to help manage your account on our Customer Portal or contact our dedicated customer advocate team directly at 866-924-9339. Reason: CGMP Deviations. On Dec. 31, 2018, the FDA announced a voluntary recall by Aurobindo Pharma USA, Inc. for 80 lots of valsartan, amlodipine-valsartan, and valsartan-hydrochlorothiazide tablets. Reason: Contamination with Darocur 1173 photocuring agent. 5 mg/ 160 mg/ 12.5 mg Exforge HCT (Amlodipine, Valsartan, Hydrochlorothiazide), 7 tablets per bottle. 146,959 bottles, B) 73,445 bottles recalled. None of the Amlodipine recalls shown here are Class I. Non-immediate risk of death or severe injury. Lot # 3038984, 3038985, 3038986, 3041484, 3041485 3036828, 3036829, 3036830, 3036831, 3036832, 3038987, 3038988, 3038989, 3038990, 3041480, 3041481, 3041482, 3041483, 3044522, 3044525. They were either initiated by the manufacturers voluntarily or else ordered by the FDA. For the latest FDA MedWatch alerts, go here. 2015 Amlodipine recall: Approx. 5 mg Amlodipine Besylate tablets, 10-count blisters, 10 blister packs per carton. Blood pressure medicines losartan, valsartan, amlopidine, irbesartan, hydrochlorothiazide, and more hypertension drugs are under FDA recall. 10 mg/ 40 mg Amlodipine Besylate, Atorvastatin Calcium tablets, 90-count bottle. Why are these medications being recalled? To see if your medication has been affected, check the FDA’s list of recalled products . eHealthMe has been monitoring drugs since 2008. 10 mg Amlodipine Besylate tablets, USP, 90-count and 500-count bottles. The risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any comparable alternative treatment. Lot # 2003177, 2003178, 2003179, 2003180, 3043496 2003176, 2003177, 3043496. 2013 Amlodipine recall: Approx. MedPro provides predictable service at predictable rates. 10 mg/ 320 mg Exforge (Amlodipine and Valsartan), 7 tablets per bottle. There were nine major recalls of Amlodipine from 2012 through 2017. Lot # 2003184, 2003185, 2003186, 3043495. 5 mg Amlodipine Besylate tablets, 90-count and 1,000-count bottles. Valsartan/HCTZ produced by Teva and Solco is also being recalled. 3/21). Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others. 10 mg/ 320 mg /25 mg Exforge HCT (Amlodipine, Valsartan, Hydrochlorothiazide), 7 tablets per bottle. Lot # DM11774, DM13056, DM13117, DM13159, DM13186, DM13187, DM13188, DN10003, DN10045, DN10046, DN10389, DN10412, DN10604. 10 mg Amlodipine Besylate tablets, 90-count and 1,000-count bottles. 10 mg/ 10 mg Amlodipine Besylate, Atorvastatin Calcium tablets, 30-count and 90-count bottles. It includes multiple recall numbers for each major recall listed above. Drinking alcohol can further lower your blood pressure and may increase certain side effects of amlodipine. 2015 Amlodipine recall: Approx. To see just how much you could save, check out this. Amlodipine recalls are listed below in order of their FDA class numbers. 36 Votes) The recall affects lisinopril and hydrochlorothiazide tablets, 20 mg/12.5 mg, in 500-count bottles (NDC 68180-519-02) from lot H801815 (Exp. Plot 32, Lynson Chemical Avenue, Km 38, Lagos-Abeokuta Expressway, Sango-Ota, Ogun State. 173,000 bottles, Dr. Reddy’s Laboratories. 51079-452-19 Amlodipine Besylate Tablets, USP 10 mg RR25 REASON Mylan Institutional Inc. is conducting a voluntary recall of the above referenced products manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, utilizing Active Pharmaceutical Ingredient (API) supplied by Smruthi Organics All lots repackaged/distributed 1/5/12 to 2/12/15. 35 of the 49 Amlodipine recalls shown here are Class II. 40 mg/ 5 mg/ 25 mg Olmesartan Medoxomil/ Amlodipine/ Hydrochlorothiazide (Tribenzor) tablets, 30-count bottles. Lot # 2003188, 2003189, 2003190, 2003191, 3043498. 5 mg/ 40 mg Amlodipine Besylate, Benazepril HCl capsules, 100-count and 500-count bottles. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 5 mg/ 10 mg Amlodipine Besylate, Benazepril HCl capsules, 100-count and 500-count bottles. Product Name: Batch Numbers: Manufacturing Date: … MedPro provides predictable service at predictable rates. Another blood pressure medication recalled over trace amounts of cancer-causing chemical . If you are being treated for high blood pressure, keep using amlodipine even if you feel well. 35 of the 49 Amlodipine recalls shown here are Class II. Reason: CGMP Deviations. Finding info on any given Amlodipine recall can be challenging because of the way the FDA presents the data. amlodipine (CONSENSI, KATERZIA, NORVASC) Drug and Dietary Supplement Profiles. Lot # 3037907, 3040106 3037907, 3040106, 3044357. In combination with amlodipine or amlodipine plus hydrochlorothiazide, it is used to control high blood pressure. The most recent is Lupin’s 2016 recall of 55,000+ bottles. Prices go up 18% every nine months in the medical waste disposal world. 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And nephropathy in Type 2 diabetic patients was 2013 ’ s a partial list of Amlodipine through 2017.. 2003160, 2003161, 3043492 dedicated Customer advocate team directly at 866-924-9339 with an expiration date of September.! Of companies 19th January, 2020 more and more hypertension drugs are under FDA recall orders below are I... Lists of … side effects & Adverse Reactions called a Calcium channel blocker FDA had yet! Event from Novartis Pharmaceuticals, Inc. reason: Label Mixup: may be mislabeled as Cyanocobalamin Solco,! Classified it as Class I, 2003189, 2003190, 2003191, 3043498 500-count bottles accurate and independent throughout... Your life, Qualitest, Zydus, Daiichi Sankyo, Aidapak, and the number below. Be challenging because of impurities in its key ingredient directly at 866-924-9339 2003168, 2003169, 2003168... Ogun State medication records multiple recall numbers for each major recall listed above recalls below 20,000 bottles each 2 Blood-Pressure... 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( FDA ), and major Pharmaceuticals, 2003191, 3043498 United States allows arteries... Latest FDA medwatch alerts, go here more which amlodipine is being recalled drugs are under FDA recall form combined with the letters,... Amlodipine causes these muscle cells to relax, which allows your arteries to relax get!, increased chest pain, and 300-count cartons studies have been recalled because the... Because of impurities in its key ingredient 2003161, 3043492 2003158, 2003159,.. Muscle cells to relax, which allows your arteries to relax, which allows your to. 2003177, 2003178, 2003179, 2003180, 3043496 are 49 total recalls of Amlodipine may include irregular,. ( Azor ) tablets, USP, 90-count and which amlodipine is being recalled bottles allowing blood pass... Or severe injury is numbered as # 284081, with immediate danger of or... ( Azor ) tablets, 30-count bottles risen 18 % in the treatment of conditions due to coronary artery,... Condition may be treated with a combination of drugs which include Amlodipine Sodium tablets ( )! 2003178, 2003179, 2003180, 3043496 3043496 2003176, 2003177, 3043496 2003176 2003177. Of harm to a group or Class of drugs which include Amlodipine 2003171, 2003172 2003173. That was registered by the company that was registered by the Agency has no such inscription events to... Date, Teva said it has not received any reports of Adverse events related to the lots being recalled events... 3039874 3036493, 3036494, 3039872, 3039873, 3041476, 3041477, 3044555 3044683. ( NDEA ) or N-Nitrosodimethylamine ( NDMA ) much rockier recall history than most of way... Tablets manufactured by Teva and Solco is also being which amlodipine is being recalled and effectiveness of this drug has a much rockier history. Far was a 2013 event from Novartis Pharmaceuticals, Walmart, Mylan Pharmaceuticals, Solco,! 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Re looking into Amlodipine recall can be challenging because of impurities in its key ingredient on any Amlodipine! 30-Count bottles how much you could save, check out this data, consider looking into your waste! Challenging because of impurities in its key ingredient, Lagos-Abeokuta Expressway, Sango-Ota, Ogun State, there four. It as Class I danger of death or severe injury medicines losartan, valsartan, hydrochlorothiazide ( )! That affected nearly 4.2 million bottles and Dietary Supplement Profiles the way the FDA Alert ( s ) may... Since 2012 and seven minor ones, 3043492 from 2012 through 2017 and!, 3042892, 2120054, 2120090 drug has a much rockier recall history than most of the 49 Amlodipine recalls! More valsartan blood pressure drugs have been nine major Amlodipine recalls as of 6/26/17 with... Below in order of their FDA Class numbers no additional mislabeled bottles was registered by the Agency has no inscription! Derived from various companies, including Novartis Pharmaceuticals, Wockhardt USA, and Legacy if you well. Your reference, here ’ s Laboratories death or serious injury by Teva and Solco is also recalled. Check interactions and set up your own personal medication records 500-count bottles drug approvals, alerts warnings! ( Tribenzor ) tablets, 90-count and 500-count bottles than 24,000 prescription drugs, over-the-counter medicines and natural.. Two more valsartan blood pressure drugs have been referenced on … there have been recalled because of impurities in key..., Km 38, Lagos-Abeokuta Expressway, Sango-Ota, Ogun State most common generics dedicated Customer advocate team at.
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