aurobindo losartan recall 2020

. Provides recall information pertaining to recalls Inmar is handling on behalf of the manufacturer. Note: Never stop taking a drug that appears on the product recall list without first talking to your doctor or pharmacist. Rated for Hypertension Report. They are listed to help users have the best reference. The recalled products have expiration dates ranging from October 2019 to July 2020. The impurity found in these batches is N-Methylnitrosobutyric acid (NMBA). about this recall, Aurobindo Pharma USA Inc., 1-866-850-2876 September 2021 Class II Entacapone 00904682204 Failed Dissolution Specifications If you have questions about this recall, The Harvard Drug Group, 1-800-875-0123. The Sandoz Inc. recall involved 100 milligram/25 milligram Losartan tablets with the lot number JB8912 and expiration date of June 2020. . Brenda April 12, 2020 at 3:28 pm I felt I was being poisoned recently by an Aurobindo brand drug that I had been taking for years with no issues. Fluphenazine Decanoate Injection. 12/03/2020 . Thursday, October 28, 2021. 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. 11/27/19 Aurobindo. Click here for an updated list of Losartan products under recall. The new recalls include: Losartan Potassium Tablets USP. Recall expansions also were announced January 3 , January 22 , March 1, and April 18. Losartan Potassium Tablets 100 mg - 90/Bottle . Expiration Date: November 2018, January 2019, March 2019, July 2019, November 2019, December 2019, January 2020, February 2020, March 2020 Tizanidine HCL 2 mg On 09/04/2018, Dr. Reddy's Lab recalled Tizanidine HCL 2 MG due to a tablet mix-up. Such a situation occurs when the use or exposure to the violative products does not cause any adverse effect. Valsartan and Hydrochlorothiazide oral tablet, Aurobindo, 320 mg/25 mg, bottle, 90 count, NDC 65862-0551-90. 2 . An enforcement report Alembic has losartan and hydrochlorothiazide tablets in 90-count presentations available. The recalls deal with only certain types of drugs called angiotensin II receptor blockers (ARBs), and more specifically, three generic medications: valsartan (brand name: Diovan), losartan (brand name: Cozaar), and irbesartan (brand name: Avapro). Losartan Potassium Tablets 25 mg - 1000/Bottle View Details. I have been taking 25 mg. of Losartan for apx. 9 USFDA. Aurobindo, and Macleods refuse to provide updated availability information. The chemical is called NMBA, which is short for N-Nitroso-N-methyl-4-aminobutyric acid. Contact. 1 Some of the previous recalls were due to N-nitrosodiethylamine (NDEA) impurity. Valsartan and Hydrochlorothiazide oral tablet, Aurobindo, 80 mg/12.5 mg, bottle, 90 count, NDC 65862-0547-90. Another pharmaceutical company is recalling blood pressure medication after detecting trace amounts of a cancer-causing chemical. Not Applicable. Update [6/26/2019] FDA is alerting patients and health care professionals to Macleods Pharmaceuticals' voluntary recall of two lots of losartan potassium tablets (50mg strength) and 30 lots of . The Global Losartan Market is driven by the growing . The Global Losartan Market was valued at $4.73 billion in 2020 and is expected to grow at a formidable rate of 7.81% during the forecast period. A recall of common blood pressure medication losartan has been expanded for a fifth time after manufacturer Torrent Pharmaceuticals found a possibly carcinogenic impurity in more batches of the . Health chiefs today recalled dozens of batches of blood pressure pills because they were found to contain an explosive chemical. . 2013-2021 *BY THE NATIONAL TRIAL LAWYERS . Click here for an updated list of Losartan products under recall. Click here for an updated list of Losartan products under recall. Aurobindo Pharma . Losartan is used to slow long-term kidney damage in people with type 2 diabetes who also have high blood pressure. Aurobindo Pharma Limited Issues Voluntary Recall of Irbesartan Drug Substance Due to the 03/2020: Aurobindo Pharma USA, Inc. Valsartan 40mg Tablet: 65862-570-30: 470180008A: 02/2020: . Indian drug firms like Marksans Pharma, Aurobindo Pharma, Zydus and Jubilant are recalling products in the US market, as per the latest enforcement report by the USFDA The recall is due to the detection of trace amounts of an unexpected impurity that might cause cancer. Torrent Pharmaceuticals recalls 60 lots of losartan potassium tablets and 54 lots of losartan potassium/ hydrochlorothiazide tablets for the detection of a new impurity, NMBA. There has been a valsartan recall, a losartan recall, an amlodipine recall, an irbesartan recall and a hydrochlorothiazide recall. Not Applicable. Mar 3, 2020 7:00am. Aurobindo refuses to provide updated availability information. Ranitidine Hydrocholoride Tablets, USP, 150 mg, 60's, 100's and 500's. The nationwide recall was initiated on 21 January 2021 due to "failed impurities/degradation specifications." This type of recall is categorized as a class III recall by the USFDA. recalls include Maylan, Aurobindo . Torrent Pharmaceuticals limit is expanding its Recall for Losartan Potassium Tablets USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP, to consumer level due to detection of trace amounts of unexpected impurity found in active Pharmaceutical ingredient manufactured by Hetero Labs limit. 01/2020: Macleods Pharmaceutical Ltd. Losartan/Hydrochlorothiazide (HCTZ . AB. Aurobindo Pharma USA recalls several lots of valsartan products due to the presence of NDEA. FDA expands recall on blood pressure drug 02:42. Alembic, Aurobindo, Cadista, Macleods, and Novartis are not affected by this recall. The FDA this month said that a third impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA), had been discovered in the API of Aurobindo losartan, leading to the recall of nearly 90 lots of that . This new recall expansion is the fifth in 2019 for Torrent's losartan products, following the initial recall on December 20, 2018. The recalled products have expiration dates ranging from October 2019 to July 2020. The latest recall notices were issued on Friday . . Not all valsartan, losartan, and irbesartan-containing medications are affected and being recalled.. Not all lots of valsartan, irbesartan, and losartan from a manufacturer involved in a recall . 179791 with expiration date 3/31/2020. time, the valsartan recall, which also includes a recall of contaminated losartan, and irbesartan, was the largest recall of generic pharmaceuticals in U.S. history. 11/22/19 Glenmark. I just started a new medication which seems to be working. Valsartan is a frequently prescribed drug in hypertension treatment. Specifications. While the FDA's investigation . Valsartan, Irbesartan, and Losartan finished products were spiked with reference standard solution in the following way: For samples with NDMA above 0.3 ppm and/or NDEA above 0.08 ppm: Spike sample solution with the reference standard solution at concentration level close to sample concentration and calculate recovery. In September 2019, Torrent Pharmaceuticals announced it was expanding its recall to an additional 3 lots of Losartan Potassium Tablets USP and 2 lots of Losartan Potassium/Hydrochlorothiazide . AurobindoPharma USA, Inc. is conducting a voluntary recall expansion of 38 lots of Valsartan and Amlodipine and Valsartan tablets to the consumer level due to the detection of trace amounts of an . Find medication information including related drug classes, side effects, patient statistics and answers to frequently asked questions. Losartan Potassium Oral tablet drug summary. Aurolife Pharma, Indian-based Aurobindo's US subsidiary, issued the recall after it was discovered that a number of products had been labelled with the wrong lot number, as well as potentially bearing the incorrect expiry date. Angiotensin II receptor blockers (ARBs) like losartan, valsartan and irbesartan are common medications used to treat high blood pressure. For more information about the losartan recall and affected products, . . If you are taking Valsartan manufactured by any of the makers below, consult with your physician regarding your next steps. Mirtazapine. September 2021 Class II Valproic Acid 06043262116 CGMP Deviations If you have questions . Aurobindo Pharma . Losartan 3-25-2020 TEVA - Tramadol Recall 1-30-2020 . Olmesartan & HCTZ Tabs 40 mg/12.5 mg, 90 View Details. Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, . Feb-2020. a year the side affects are shortness of breath walking up one flight of stairs and panting for 5 minutes , eye yellowing and dryness, loose bowel movements, weight gain and fatigue, urination has changed to dribbling, wheezing and dry cough. FTC delays Novartis' Sandoz deal with Aurobindo into 2020: report The drugmaker says it still believes FDA action will not have any significant impact on its revenues or the supplies for its U.S . FDA expands recall on blood pressure drug 02:42. CALL NOW FOR A. The Valsartan Recall List. Product Recalls: April 15, 2020 - May 13, 2020. Sandoz's losartan potassium/hydrochlorothiazide (100 mg/25 mg) tablets; NDC 0781-5207-10; Lot #: JB8912; Exp. recalls include Maylan, Aurobindo . Lupin is not actively marketing valsartan tablets. AB. 01/2020: 65862-739-30 . But the Gurgaon-based company is not the only Indian drugmaker to voluntarily recall drugs from the US market this year. Note: This story was updated on Sept. 23, 2019, with an additional losartan recall from Torrent Pharmaceuticals. I have stopped taking the medication but still . Warnings. 11/26/19 AuroMedics. Update . Have been taking Avapro since June 2020, Couldn't figure out why I had such extreme headaches. Aurobindo Pharma- recalls Acetaminophen injection. FDA alerts patients and health care professionals to Aurobindo's recall of valsartan medication due to NDEA. Losartan is used to treat high blood pressure (hypertension). MFR acetaZOLAMIDE ER 500 MG (NDC 50742023301) INGENUS PHARMACEUTICALS. 12/2020: Aurobindo Pharma USA, Inc. . The voluntary recall was expanded to 40 additional lots of 25 mg, 50 mg and 100 mg losartan tablets on March 19, 2019 and again on April 24, 2019 to include four repackaged lots of losartan . 3 alerts/teva-pharmaceuticals-usa-issues-voluntary-nationwide-recall-valsartan-and-valsartan (accessed 12 Dec 2020). The recall was prompted by the discovery of cancer-causing impurities in the medications. Benicar HCT®. 100 mg. 65862020390. Valsartan and Hydrochlorothiazide oral tablet, Lupin, 160 mg/12.5 mg, bottle, 90 count, NDC 68180-0104-09. East Windsor, N.J. -Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Fenofibrate Capsules USP, 67mg, 134mg, and 200mg. recalls include Maylan, Aurobindo Pharma . Patients prescribed angiotensin II receptor medications have filed Losartan recall lawsuits against drug manufacturers. Drug company Sandoz . lot number 179791 that expire on March 31, 2020. Click here for an updated list of Losartan products under recall. Read more about Aurobindo, Zydus, Jubilant, others recall various products in US market on Business Standard. The Medicines and Healthcare products Regulatory Agency's (MHRA) announced on July 5, 2018 a valsartan recall in Europe. On July 2, 2020, it was announced that Major Pharmaceuticals issued a consumer-level recall on Metformin Hydrochloride Extended-Release 500mg Tablets, 10×10 Unit Dose with NDC #00904-5794-61. The recall totals 2,352 bottles of simvastatin tablets, each of which contains 1,000 tablets. Alternative Recommendations for Aurobindo Losartan Potassium Recall Here, all the latest recommendations for Aurobindo Losartan Potassium Recall are given out, the total results estimated is about 20. M813513. MFR busPIRone HCl 5 MG (NDC 23155002305) HERITAGE PHARMACEUTICALS. Product News Aurobindo Receives FDA Approval for Fenofibrate Capsules, 67mg, 134mg, and 200mg. Mylan has valsartan tablets available. . Cozaar®. 25021-701-02. FTC delays Novartis' Sandoz deal with Aurobindo into 2020: report The drugmaker says it still believes FDA action will not have any significant impact on its revenues or the supplies for its U.S . Losartan Latest BP Drug Recalled for Contamination. Cadista has temporarily discontinued losartan tablets due to issues with obtaining active ingredient. Nov. 13, 2018 -- Yet another blood pressure drug has been recalled because of fears of impurities added by a lab in China. A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco) Dextrose Injection, USP. . The affected product was not distributed prior to Oct. 8 . Olmesartan & HCTZ Tabs 40 mg/25 mg, 30 View Details. Date 06/2020. NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen according . March 18, 2019 4:15 PM PDT. Torrent Pharmaceuticals Limited is expanding the recall of certain Losartan blood pressure medications. . The recalled products have expiration dates ranging from October 2019 to July 2020. Aurobindo adds value through superior customer service in the distribution of a broad line of generic pharmaceuticals, leveraging vertical integration and efficient controlled processes. Visit cvs.com for more details. The drug manufacturer, Aurobindo Pharma USA, issued a voluntary recall of the medication due to detected trace amounts of an impurity, N-nitrosodiethylamine (NDEA). Register Login . DailyMed. H000844, H000964, H804311, H805267, H805268, H805269, . Doctors regularly prescribed antihypertensive drugs like Losartan, Valsartan, and Irbesartan to millions of patients in the United States and worldwide.The FDA found that more than a dozen manufacturers produced prescription drugs with unsafe levels of several probable human . Torrent Pharmaceuticals recalls 60 lots of losartan potassium tablets and 54 lots of losartan potassium/ hydrochlorothiazide tablets for the detection of a new impurity, NMBA. Update . January 25, 2019 . The recall was issued due to one lot of Metformin being tested and showed results for NDMA levels in excess of the Acceptable Daily Intake Limit. Losartan Potassium Tablets 100 mg - 90/Bottle View Details. Health Letter, June 2020. Read more about Aurobindo drug recalled in the US on Business Standard. The 160 mg tablets come . Between July 2018 and September 2019, the U.S. Food and Drug Administration (FDA) announced the recall of hundreds of lots of blood pressure drugs. Losartan Recall. The United States Food and Drug Administration (FDA) has issued more recalls for the blood pressure medication losartan. Do not use losartan if you are pregnant. Cadista states the shortage is due to an FDA import alert. Consumers with medical questions regarding this recall or to report an adverse event can contact Aurobindo Pharma USA, Inc. at: 1-866-850-2876 Option 2 pvg@aurobindousa.com Any general questions regarding the return of this product please contact GENCO Pharmaceutical Services at (877) 475-5864 or (live calls received 9 am -5:00 pm Central Time). 40 mg /12.5 mg. 65862078090. MFR Albuterol Sulfate (2.5 MG/3ML) 0.083% (NDC 00487950125) NEPHRON PHARMACEUTICALS CORP. MFR Amiodarone HCl 400 MG (NDC 42494030903) CAMERON PHARMACEUTICALS. Reference Brand: . UPDATE - Macleods Pharmaceuticals voluntarily recalls losartan containing NMBA. Most recalls are limited to a single manufacturer and may not be related to the version of a particular drug you are taking. DailyMed. 12/2/19 Hospira. The 100 mg/12.5 mg tablets and 100 mg/25 mg tablets in 1,000-count bottles are on back order and the company cannot estimate a release date. It is also used to lower the risk of stroke in certain people with heart disease. Beginning in mid-2018, Torrent has now recalled more than 300 lots of blood pressure medication for containing NMBA above the FDA's acceptable limit. Aurobindo adds value through superior customer service in the distribution of a broad line of generic pharmaceuticals, leveraging vertical integration and efficient controlled processes. The first recall was in July 2018 when China's Zhejiang Huahai Pharmaceuticals recalled batches of valsartan for trace amounts of NDMA. Estimated Resupply Dates. On Friday, Ranbaxy Laboratories voluntarily recalled a few batches of generic Lipitor from the US market. The other two are N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA). The reason for this is an impurity at the Chinese manufacturer Zhejiang Huahai Pharmaceutical. Find out which specific blood pressure medications are affected by the recall. Avet discontinued losartan tablets in 2021. Losartan was recalled due to impurities found while testing finished products. Teva Pharmaceuticals and Aurobindo Pharma USA are just a couple of the manufacturers involved in these widespread high blood pressure medication recalls. Communications related to ARB recalls: Auro Pharma Inc. voluntarily recalls one lot of Auro-Irbesartan HCT tablets because of nitrosamine impurity (information update April 4, 2019); Pro Doc Limitée voluntarily recalls two lots of irbesartan drugs because of nitrosamine impurity (information update, March 14, 2019); Multiple Losartan-containing drugs voluntarily recalled because of potential . 90. Below is a list of the current Valsartan makers and the recalled Valsartan and Losartan products they provide. Auro Pharma Inc. is recalling seven lots of prescription losartan tablets, in 25 mg, 50 mg and . RELATED: Valsartan recall expands with Aurobindo issuing recall of its high blood-pressure drug. 13668-409-10 - 50mg, 1000 count, 4DU2E009, expires 12/31/2020; 13668-115-90 - 100mg, 90 count, 4DU3E009, expires 12/31/2020; 13668-115-10 - 100mg, 1000 count, 4DU3E018, expires 02 . The recalled products have expiration dates ranging from October 2019 to July 2020. . VCF Brand Vaginal Contraceptive Foam. recalls include Maylan, Aurobindo . Aurobindo expanded its recall of Valsartan and Torrent expanded its recall of Losartan, the latter after finding a new possible carcinogen, NMBA, in the active ingredient. UPDATE (October 1, 2021): Auro Pharma Inc. recalls certain lots of losartan due to azido impurity. NDEA appears to cause cancer in animals and is suspected to cause cancer . (Note: If you're taking a brand-name drug, your medication was not affected by the recalls.) This recall is due to an impurity called N-nitrosodiethylamine (NDEA) in some products that contain losartan, valsartan or irbesartan. A previous valsartan recall by manufacturer Aurobindo Pharma for too much NDEA (N-Nitrosodiethylamine) beget this recall of lot No. The pills come in 100-count . Aurobindo on its own or through its subsidiaries . losartan and irbesartan, leading to a shortage of losartan. Furthermore, Aurobindo Pharma Limited issued a voluntary recall of irbesartan drug substance due to the detection of trace amounts of NDEA. January 14, 2020 Page 3 more Losartan product recalls (505 lots), manufactured by multiple defendants.1 Of the 17 Losartan recalls totaling 506 lots, 12 were due to the presence of NDEA in the medications and 15 were due to the presence of N-Nitroso N-Methyl 4-Amino Butyric Acid (NMBA) in the medications. Aurobindo Pharma U.S.A. Amlodipine Valsartan, . 90. Pharmacies stocking the affected drugs — several different types . The recall of heart drugs has expanded again to include Torrent Pharmaceuticals losartan potassium and Aurobindo Pharma USA Inc. drugs containing valsartan. Contact 279 Princeton Hightstown Road East Windsor, NJ 08520 Case 1:20-cv-21456-XXXX Document 1 Entered on FLSD Docket 04/03/2020 Page 1 of 41. This is the third type of impurity to cause recalls of these medications. In July 2018, valsartan was the first blood pressure drug recalled. Valsartan Recall: Blood pressure drug affected by impurity. Rebekah October 24, 2021 at 1:32 pm Situation occurs when the use or exposure to the violative products does not cause any adverse.. Bottles of simvastatin tablets, each of which contains 1,000 tablets because of fears of impurities added by lab! Information pertaining to recalls Inmar is handling on behalf of the manufacturers involved in these batches is acid. Mg and Sandoz & # x27 ; s losartan potassium/hydrochlorothiazide ( 100 mg! 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