losartan recall april 2020

It is also used to lower the risk of stroke in certain people with heart disease. Outcome reported as the mean number of days participants in each arm did not require ventilator use. In rare cases, Cozaar may cause a severe allergic reaction, which can include hives, itching, rash, or trouble breathing. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04311177. This time, the recall affects 5 lots: 3 lots of losartan potassium tablets and 2 lots of losartan/hydrochlorothiazide tablets. The recall of Torrent's Losartan products was initially announced December 20, 2018, and was expanded on January 3, 2019. h�bbd```b``�"�� L��'A$��&��-`�O�l6�l�&�4��}"��$�] ɸ��p��$�� QD�g`�� S Females able to have children not currently taking a protocol allowed version of contraception: intrauterine device, Depo-formulation of hormonal contraception (e.g. 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). Study record managers: refer to the Data Element Definitions if submitting registration or results information. Outcome reported as the number of participants in each arm who fall into each of 7 categories. Nov. 13, 2018 -- Yet another blood pressure drug has been recalled because of fears of impurities added by a lab in China.. Drug company Sandoz says it has recalled one lot of losartan … Class 3 Recall: Using the drug is not likely to cause adverse health consequences. Health Letter, June 2020. 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? 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). The PROMIS Dyspnea (shortness of breath) item banks and pools assess self-reported shortness of breath in general, intensity, frequency and duration on a 0-10 scale, with 0 being no symptoms and 10 being the most severe. History of chronic kidney disease stage IV, Estimated Glomerular Filtration Rate (eGFR) of < 30ml/min/1.73 m2 (must be have been measured within 1 month of enrollment), Other kidney disease that in the opinion of the investigator, would affect losartan clearance, Patient reported dehydration and significantly decreased urine output in the past 72 hours, Most recent systolic blood pressure prior to enrollment <110 mmHg, Other liver disease that in the opinion of the investigator, would affect losartan clearance, Documented AST or ALT > 3 times the upper limit of normal within 3 months of randomization (if available in electronic medical record), Potassium >5.0 mmol/L (must have been measured within 1 month) of enrollment, Enrollment in another blinded randomized clinical trial for COVID.

A-S Medication Solutions LLC (Teva/Actavis & Prinston/Solco) Check out what's clicking on Foxnews.comTorrent Pharmaceuticals Limited said its Losartan Potassium Tablets USP and Losartan Potassium/hydrochlorothiazide tablets, USP, are affected by the recall.The ingredient detected was identified as N-Methylnitrosobutyric acid (NMBA), a known animal and potential human carcinogen. Losartan; 25 mg daily; oral administration. 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. 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. 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. 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. 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. DATE OF RECALL: April 15, 2020. 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. Losartan side effects. A widespread recall of common blood pressure and heart failure medications has been expanded to include more drugs containing losartan. Outcome reported as the mean number of days participants in each arm did not require therapeutic oxygen use. This prompted the first recall of valsartan medicines due to the presence of a cancer-causing substance called N-nitrosodimethylamine (NDMA) in July 2018. All participants of child bearing potential enrolled in this fashion will be informed of the teratogenic risks. April 1, 2020. h�b``e``�� $��P#�0p4 ��B1�&� �=�Y�KL��/3�0v3�a��`��a��^�-+�^��00�$�d�}1��H&Uv�(�@� n�� Losartan is used to slow long-term kidney damage in people with type 2 diabetes who also have high blood pressure. Share. Genetic and Rare Diseases Information Center. 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 Lakartidningen. Manufacturers face thousands of lawsuits from Zantac users who claim their cancer was caused by the contaminated drug. LOSARTAN POTASSIUM and HYDROCHOLOROTHIAZIDE TABLETS, USP 50mg/12.5 mg, 1000 count bottles, NDC number 13668-116-10, Lot BEF7D006, expiration date 3/2020. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). 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. Participants in this arm will receive a placebo treatment. The FDA lab Participants in this arm will receive the study drug, Losartan. The SF-12 is a self-reported validated outcome measure assessing the impact of health on an individual's everyday life. How Do I Know if my Valsartan Has Been Recalled? A total of 16 lots have been recalled, all at the consumer level. 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. Teva Pharmaceuticals has recalled an additional six lots of bulk losartan potassium tablets, expanding a nationwide recall originally initiated in April, the FDA announced June 11. Contadina Pizzetas and Del Monte Veggieful Bites. Facebook; Twitter; Email; Note: Never stop taking a drug that appears on the product recall list without first talking to your doctor or pharmacist. 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. Outcome is reported as the mean number of emergency department and clinic presentations combined per participant in each arm. Added March 25, 2020 Reason for recall… The affected lots are being recalled due to an unexpected impurity in the manufacturers’ active pharmaceutical ingredient (API). 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 106 0 obj <> endobj Nexplanon), daily oral contraceptives with verbalized commitment to taking daily throughout the study, condom use or abstinence during the study. The Sandoz Inc. recall involved 100 milligram/25 milligram Losartan tablets with the lot number JB8912 and expiration date of June 2020. endstream endobj startxref 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. Losartan is used to treat high blood pressure (hypertension). This is part of an ongoi n g issue with angiotensin II receptor blocker (ARB) medications. The new lot is … Currently, there is a pre-planned pooled analysis with a national trial network under development. Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration. Drug Recall . This time, the recall affects 5 lots: 3 lots of losartan potassium tablets and 2 lots of losartan/hydrochlorothiazide tablets. Outcome is reported as the mean maximum daily body temperature (in degrees Celsius) over 10 days. Total scores range from 0 to 99 with higher scores reflecting greater levels of dyspnea during daily activity. 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. 2020 Jul 13;117. pii: 20110. %%EOF All forms of Zantac have been recalled as of April 2020. Losartan may also be used for purposes not listed in this medication guide. Search List of Recalled Angiotensin II Receptor Blockers (ARBs) including Valsartan, … The recall is … There is no validated, unified single score and each item is evaluated individually. … 0 FDA expands blood pressure drug recall for fifth time this year. COVID-19 is an emerging, rapidly evolving situation. For general information, Learn About Clinical Studies. 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. Outcome reported as the percent of participants in each arm who require oxygen therapy by day 15 following randomization. Read our, ClinicalTrials.gov Identifier: NCT04311177, Interventional 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 …

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