losartan recall april 2020

According to the new guidelines, a reading of 130/80 is considered high blood pressure, a change that adds 30 million U.S. adults to the bucket of those with the condition. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Losartan; 25 mg daily; oral administration. Viral load is measured as number of viral genetic copies per mL. medroxyprogesterone acetate/Depo-Provera), subcutaneous contraceptive (e.g. Nexplanon), daily oral contraceptives with verbalized commitment to taking daily throughout the study, condom use or abstinence during the study. %PDF-1.6 %�� Class 3 Recall: Using the drug is not likely to cause adverse health consequences. [COVID-19 and kidney disease]. Published: 5:06 PM CDT April 29, 2019 ... TYLER, Texas — The FDA announced another recall for certain lots of Losartan tablets. Important recall information for Losartan Potassium 100mg Tablets We wanted to let you know that certain manufacturers have issued a recall of select lots of Losartan Potassium 100mg Tablets. All participants of child bearing potential enrolled in this fashion will be informed of the teratogenic risks. Currently, there is a pre-planned pooled analysis with a national trial network under development. Please remove one or more studies before adding more. Torrent Pharmaceuticals Limited announced it is including an additional 36 lots of Losartan potassium Tablets USP and 68 lots of Losartan Potassium/Hydrochlorothiazide Tablets USP in … The most common possible side effects of losartan include dizziness, stuffy nose, back pain, chest pain, diarrhea, high potassium levels, low blood pressure, low blood sugar, and tiredness (FDA, 2018-a). Outcome is reported as the mean number of emergency department and clinic presentations combined per participant in each arm. 129 0 obj <>/Filter/FlateDecode/ID[<5A889D6DB4DAFA4F8EA35F706136DAE1><7F38F4CC80873B44A0765239831AEB53>]/Index[106 37]/Info 105 0 R/Length 107/Prev 140842/Root 107 0 R/Size 143/Type/XRef/W[1 3 1]>>stream Participants in this arm will receive the study drug, Losartan. The presence of NDMA in minute quantities has already led to the recall of many types of blood pressure medications, such as valsartan and losartan. Physical score is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Added April 10, 2020 Reason for recall: May Contain Small Rocks Products: HealthyChoice Powerbowl Chicken Feta and Farro 9.5 ounces (072655-00180) Use by Date October 19, 2020 ONLY. Outcome reported as the number of participants in each arm who fall into each of 7 categories. Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, … A losartan recall class action lawsuit seeks reimbursement and medical monitoring for all who bought and used tablets tainted with a cancer-causing impurity. Smolander J, Bruchfeld A. An … Read our, ClinicalTrials.gov Identifier: NCT04311177, Interventional Talk with your doctor and family members or friends about deciding to join a study. The FDA released a list of all … How Do I Know if my Valsartan Has Been Recalled? Lower scores indicate greater condition severity. RECALLING FIRM: Avet Pharmaceuticals, Inc. REASON FOR RECALL: This recall is being issued due to CGMP Deviations. This time, the recall affects 5 lots: 3 lots of losartan potassium tablets and 2 lots of losartan/hydrochlorothiazide tablets. COVID-19 is an emerging, rapidly evolving situation. The recall was expanded again in April to include 36 lots of losartan potassium tablets and 68 lots of losartan potassium/hydrochlorothiazide tablets. 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. Swedish. h�bbd```b``�"�� L��'A$��&��-`�O�l6�l�&�4��}"��$�] ɸ��p��$�� QD�g`�� S 142 0 obj <>stream (Clinical Trial), Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor), Randomized Controlled Trial of Losartan for Patients With COVID-19 Not Requiring Hospitalization, 18 Years and older (Adult, Older Adult), Minneapolis, Minnesota, United States, 55415, M Health Fairview University of Minnesota Medical Center, Minneapolis, Minnesota, United States, 55455, Rochester, Minnesota, United States, 55415. Manufacturers face thousands of lawsuits from Zantac users who claim their cancer was caused by the contaminated drug. Teva Pharmaceuticals’ April recall of blood pressure and heart medication losartan has been expanded by six bulk lots after the possibly cancerous impurity NMBA was found in the active ingredient. The lot numbers involved in the earlier recall were 180190 and 180191 (with an October 2020 expiration date) and 181597 (with a February 2021 expiration). ... Gail April … Participants will report their maximum daily oral temperature to the study team. Outcome reported as the number of participants per arm admitted to inpatient hospital care due to COVID-19-related disease within 15 days of randomization. Participants will collect oropharyngeal swabs every third day for the duration of study participation. endstream endobj 107 0 obj <. Class 2 Recall: Using the drug may cause temporary or medical reversible adverse health consequences, the probability of serious adverse health consequences is remote. A full list of the recalled products is posted on the FDA's website.Products can be identified by checking the product name, manufacturer details, and batch or lot number on the pill bottles. Outcome reported as the percent of participants in each arm who require oxygen therapy by day 15 following randomization. … 2020 Jul 13;117. pii: 20110. In rare cases, Cozaar may cause a severe allergic reaction, which can include hives, itching, rash, or trouble breathing. Genetic and Rare Diseases Information Center. A widespread recall of common blood pressure and heart failure medications has been expanded to include more drugs containing losartan. Randomized Controlled Trial of Losartan for Patients With COVID-19 Not Requiring Hospitalization: Actual Study Start Date : April 9, 2020: Estimated Primary Completion Date : April 1, 2021: Estimated Study Completion Date : April 1, 2021 A total of 16 lots have been recalled, all at the consumer level. This time, the recall affects 5 lots: 3 lots of losartan potassium tablets and 2 lots of losartan/hydrochlorothiazide tablets. endstream endobj startxref Losartan Recall Lawsuit Losartan is a popular blood pressure medication that has been voluntarily recalled multiple times due to the presence of a human carcinogen. Outcome reported as the mean number of days participants in each arm did not require ventilator use. Losartan is used to treat high blood pressure (hypertension). UPDATE - Teva expands its voluntary recall of losartan Update [6/12/2019] Teva Pharmaceuticals is expanding its voluntary recall to include seven additional lots of losartan potassium tablets (three lots of 50 mg strength and four lots of 100 mg strength) labeled by Golden State Medical Supply. %%EOF h�b``e``�� $��P#�0p4 ��B1�&� �=�Y�KL��/3�0v3�a��`��a��^�-+�^��00�$�d�}1��H&Uv�(�@� n�� There is no validated, unified single score and each item is evaluated individually. Added March 25, 2020 Reason for recall… This is part of an ongoi n g issue with angiotensin II receptor blocker (ARB) medications. The SF-12 is a self-reported validated outcome measure assessing the impact of health on an individual's everyday life. Update - Recall expanded. It is also used to lower the risk of stroke in certain people with heart disease. The 33-item Severity bank assesses the severity of difficulty breathing during various specific activities (the same 33 activities assessed in Dyspnea Functional Limitations). This prompted the first recall of valsartan medicines due to the presence of a cancer-causing substance called N-nitrosodimethylamine (NDMA) in July 2018. Each activity is rated in terms of degree of dyspnea (0 = no shortness of breath, 1 = mildly short of breath, 2 = moderately short of breath, 3 = severely short of breath) while engaging in the activity over the past 7 days. The SF-12 is a self-reported validated outcome measure assessing the impact of health on an individual's everyday life. Torrent Pharmaceuticals Ltd. has expanded its recall of losartan potassium and losartan potassium/hydrochlorothiazide tablets. LOSARTAN POTASSIUM and HYDROCHOLOROTHIAZIDE TABLETS, USP 50mg/12.5 mg, 1000 count bottles, NDC number 13668-116-10, Lot BEF7D006, expiration date 3/2020. Health Letter, June 2020. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. April 17, 2020 - Buckhead Meat and Seafood of Houston - Recall of Frozen Flounder Sysco is the global leader in selling, marketing and distributing food products to restaurants, healthcare and educational facilities, lodging establishments and other customers who prepare meals away from home. Product Recalls: April 15, 2020 – May 13, 2020. Contadina Pizzetas and Del Monte Veggieful Bites. Females able to have children not currently taking a protocol allowed version of contraception: intrauterine device, Depo-formulation of hormonal contraception (e.g. Keywords provided by University of Minnesota: Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number): Why Should I Register and Submit Results? Facebook; Twitter; Email; Note: Never stop taking a drug that appears on the product recall list without first talking to your doctor or pharmacist. The FDA lab Outcome is reported as the mean maximum daily body temperature (in degrees Celsius) over 10 days. Finally, the patient answers the question "I've been short of breath" using a 0-4 scale, 0 being none and the most severe. Choosing to participate in a study is an important personal decision. Patient reported history or electronic medical record history of kidney disease, defined as: Patient reported history or electronic medical record history of severe liver disease, defined as: To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Product Manufactured in and Exported from the U.S.: Hospital Admission [ Time Frame: 15 days ], Change in PROMIS Dyspnea scale [ Time Frame: 10 days ], Change in SF-12 Physical Composite Score [ Time Frame: 10 days ], Change in SF-12 Mental Composite Score [ Time Frame: 10 days ], Daily Maximum Temperature [ Time Frame: 10 days ], Emergency Department/Clinic Presentations [ Time Frame: 28 days ], Disease Severity Rating Day 7 [ Time Frame: 7 days ], Disease Severity Rating Day 15 [ Time Frame: 15 days ], Disease Severity Rating Day 28 [ Time Frame: 28 days ], Viral Load by Oropharyngeal Swab Day 9 [ Time Frame: 9 days ], Viral Load by Oropharyngeal Swab Day 15 [ Time Frame: 15 days ], Ventilator-Free Days [ Time Frame: 28 days ], Therapeutic Oxygen-Free Days [ Time Frame: 28 days ], Need for Hospital Admission at 15 Days [ Time Frame: 15 days ], Need for Oxygen Therapy at 15 Days [ Time Frame: 15 days ], Positive laboratory test for COVID-19 based on local laboratory standard, Age greater than or equal to 18 years of age, One of the following: Upper respiratory symptoms (cough, rhinorrhea) or fever (>101.5) or loss of taste / smell, Randomization > 72 hours of meeting inclusion criteria, Currently taking an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin receptor blocker (ARB), Prior reaction or intolerance to an ARB or ACE inhibitor, including but not limited to angioedema. The latest recall comes after Torrent Pharmaceuticals expanded its recall of losartan … 0 Study record managers: refer to the Data Element Definitions if submitting registration or results information. The recall of Torrent's Losartan products was initially announced December 20, 2018, and was expanded on January 3, 2019. The affected lots are being recalled due to an unexpected impurity in the manufacturers’ active pharmaceutical ingredient (API). Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration. Mental composite score is computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health. Losartan side effects. Drug Recall . DRUG NAME: Losartan Potassium 50mg & 100mg Tablets . Wednesday's Losartan Potassium recall marks a continuation of the April 25 investigation into this medication By Haley Hunt • Published June 12, 2019 • Updated on June 12, 2019 at 8:41 pm April 1, 2020. Lakartidningen. Losartan is used to slow long-term kidney damage in people with type 2 diabetes who also have high blood pressure. Outcome reported as the mean number of days participants in each arm did not require therapeutic oxygen use. * Drug Recall Class Class 1 Recall: Reasonable probability that using the drug will cause serious adverse health consequences or death. The company added five lots of the generic drug losartan (three lots of losartan potassium tablets and two lots of losartan potassium/hydrochlorothiazide tablets) to an April recall of more than 100 lots of the same medications. Into each of 7 categories face thousands of lawsuits from Zantac users who claim their cancer caused., losartan cases, Cozaar may cause a severe allergic reaction, which include... 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