Rena-Cleanse products were promoted with statements such as, Our formula contains herbs that will kill ANY urinary infections, clean and repair the kidneys and it is also a diuretic. Some side effects can be serious. Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way. For more information, use the link below. Cut III Heads for Planers by GENERAL INTERNATIONAL, Lux Rosuvastatin, sold under the brand name Crestor among others, is a statin medication, used to prevent cardiovascular disease in those at high risk and treat abnormal lipids. Rosuvastatin: Uses, Dosage, Side Effects, Warnings - Drugs.com Please select from one of these options: If you believe that a dietary supplement (e.g., vitamin, mineral, or herbal supplement) or other nutritional product has caused A drug recall is the most effective way to protect the public from a defective or potentially harmful product. The company warned consumers on Monday of several tainted lots . You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. URL of this page: https://medlineplus.gov/druginfo/meds/a603033.html. Availability: Unavailable. Do not let anyone else take your medication. of 30 Carbide Insert Knives and 30 Replacement Screws for LuxCut III Your IP: Rosuvastatin is used together with diet, weight-loss, and exercise to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease. Lowering your blood level of cholesterol and fats with rosuvastatin has been shown to prevent heart disease, angina (chest pain), strokes, and heart attacks. Rosuvastatin (Crestor) is a statin used to lower your cholesterol to help protect your heart and blood vessels from serious, and even life-threatening, medical problems, such as heart attack or stroke.Rosuvastatin (Crestor) isn't meant to lower cholesterol on it's own. Set Do not take a double dose to make up for a missed one. The site is secure. Heads, Set Description: Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7971-3, 2022 Recall.Report / Contact / Privacy Policy. Updated date | Cut III Heads for Jointers by PIONEER, Lux Alcohol can increase the risk of serious side effects. Cut III Heads for Planers by POWERMATIC, Lux Cut III Heads for Jointers by RELIANT, Lux Updated: Torrent Pharmaceuticals Limited Expands Voluntary Nationwide Please %PDF-1.7 % Learn how to enable it, Only to contact you for additional information, As complete as possible, including strength, If different from brand/distributor above, Five Leaf Pet Botanicals Warned by FDA for Drug Claims, Gadget Island, Inc. Safety updates were omitted in the Product Insert/Medication Guide (MG), Product contains undeclared tadalafil and sildenafil, Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution; Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution. this in Address 1 or 2, but also include your physical street address in the Cut III Heads for Jointers by BRIDGEWOOD, Lux Blood pressure medication recall: What you need to know Rosuvastatin 5 mg film-coated tablets PL 20075/0402 publish it. Contact FDA For More Info 855-543-DRUG (3784) and press 4 druginfo@fda.hhs.gov Report a Serious Problem to MedWatch Complete and submit the report Online. about possible delays as well as tracking information. Statins 'vastly superior' to supplements to cut heart attack risk - NPR Please include what you were doing when this page came up and the Cloudflare Ray ID found at the bottom of this page. Only a few cases of rhabdomyolysis occur per million people taking statins. Cut III Heads for Jointers by WOODTEK, Lux account on our website, it will serve you to check out faster with your next Note: We ship most larger orders per UPS or FedEx but smaller items often ship For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety. 13 Jan 2023, The Therapeutic Goods Administration is part of the Health Products Regulation Group, Australian Government Department of Health, EZALO Composite Pack 10mg+20mg ezetimibe 10mg tablets and rosuvastatin (as calcium) 20mg tablets composite pack, PHARMACOR ROSUVASTATIN 20 Rosuvastatin (as calcium) 20 mg tablets blister pack, PHARMACOR ROSUVASTATIN 40 Rosuvastatin (as calcium) 40 mg tablets blister pack, ROSUZET Composite Pack 10mg+20mg ezetimibe 10mg tablets and rosuvastatin (as calcium) 20mg tablets composite pack, ROSUZET Composite Pack 10mg+40mg ezetimibe 10mg tablets and rosuvastatin (as calcium) 40mg tablets composite pack, APX-ROSUVASTATIN rosuvastatin (as calcium) 10mg tablet blister pack, APX-ROSUVASTATIN rosuvastatin (as calcium) 40mg tablet blister pack, CAVSTAT 40 rosuvastatin (as calcium) 40 mg tablets blister pack, CROSUVA 10 rosuvastatin (as calcium) 10mg tablet blister pack, ROSUVASTATIN LUPIN Rosuvastatin (as calcium) 10 mg tablets blister pack, ROSUVASTATIN LUPIN Rosuvastatin (as calcium) 20 mg tablets blister pack, ROSUVASTATIN LUPIN Rosuvastatin (as calcium) 40 mg tablets blister pack, ROSUVASTATIN LUPIN Rosuvastatin (as calcium) 5 mg tablets blister pack, BLOOMS THE CHEMIST ROSUVASTATIN rosuvastatin (as calcium) 10mg tablet blister pack, BLOOMS THE CHEMIST ROSUVASTATIN rosuvastatin (as calcium) 5mg tablet blister pack, Commercial Changes / Commercial viability, Alternative generic products are available, Reduction in supply until supply is exhausted, Reporting adverse events involving medicines, vaccines or medical devices, Report an issue with packaging or storage of a medicine, Help us promote adverse event reporting: promotional resources kit, Early Warning System: consumer questions and answers, Early Warning System: health professional questions and answers, Black Triangle Scheme: Information for sponsors, Database of Adverse Event Notifications (DAEN), COVID-19 vaccine safety monitoring and reporting, COVID-19 vaccine advertising and import compliance, Information for consumers and health professionals, Travelling with medicines and medical devices, Buying medicines and medical devices online, Medicinal cannabis: importation and the traveller's exemption, Accessing medicines during a medicines shortage, Transvaginal (urogynaecological) surgical mesh hub, MedSearch | Medicine information search app, Medicine shortages: Information for Health Professionals, Accessing medicines during a medicine shortage, Labelling changes: information for health professionals, Registration of medicines for the medical termination of early pregnancy, Prescribing medicines in pregnancy database, Medicine Shortages Information Initiative, Fast track approval pathways for prescription medicines, Breast implant associated-anaplastic large cell lymphoma (BIA-ALCL), Changes to labelling and regulation of hard surface disinfectants (commencing 1 April 2019), Information for medical practitioners on pending up-classification of surgical mesh devices, Advice about medical devices for health professionals, Regulation of stem cell treatments: information for practitioners, Australian Adverse Drug Reactions Bulletin, Medical device incident reporting & investigation scheme (IRIS) articles, Health professional information & education, Health professional educational materials, Overview of applying for market authorisation, Overview of medical devices and IVD regulation, Useful resources for business and researchers, How therapeutic goods are regulated in Australia, Australian Regulatory Guidelines for Prescription Medicines, Forms for complementary medicine sponsors, Australian Regulatory Guidelines for Biologicals, Regulation of platelet-rich plasma (PRP), platelet-rich fibrin (PRF) and conditioned serum, Forms for the blood and blood components industry, Disinfectants, sterilants and sanitary products, Scheduling committees meeting dates and decisions timeframes, Report a perceived breach or questionable practices, Consent to import, supply or export goods that do not comply with standards, Cancellation requested by the sponsor - regulatory actions, Failure to pay annual charges - regulatory actions, Information & notices about TGA fees & payments, TGA Business services: getting started with the TGA, TGA Business services - how to use the site, Links to international agencies & organisations, Medicines and Medical Devices Regulation Review, Back to ALL shortages and discontinuations, Back to CRITICAL shortages and discontinuations. If you have experienced an unexpected and adverse reaction to a dietary supplement, nutritional product, or generic drug, we would like to hear about it, as we may investigate the problem. ROSUVASTATIN CALCIUM Recall D-0520-2023 - Product Safety Recalls All rights reserved. of 10 Carbide Insert Knives and 10 Replacement Screws for LuxCut III Crestor | Information on Uses, Dosages, Warnings & Recalls - Drugwatch The usual starting dose is 10 mg to 20 mg once daily. Atorvastatin is the generic name for a widely prescribed statin medication, originally prescribed under the brand name Lipitor. ROSUZET Composite Pack 10mg+20mg ezetimibe 10mg tablets and rosuvastatin (as calcium) 20mg tablets composite pack. Medicines in the statin class include atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, and simvastatin. Omega-3 Supplements for Dogs and Cats Recalled Due to Potential for Vitamin A Toxicity There are several actions that could trigger this block including submitting a certain word or phrase, a SQL command or malformed data. It works in two ways. For information about reporting serious reactions and problems with medical products to the U.S. Food and Drug Administration through its MedWatch reporting program, please visit the FDA MedWatch website. In addition, these products were found to be adulterated because they are unapproved new animal drugs. Rosuvastatin may also be used together with diet to decrease the amount of cholesterol and other fatty substances in the blood in children and teenagers 8 to 17 years of age who have familial heterozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally). 01 Sep 2023. Product description. Recalls that are not indicated as being terminated are either ongoing or completed. Whereas most patients tolerate statins without problems, statin-associated myopathy is well documented, as are several risk factors. PDF OMB Control No.: 2127-0004 Part 573 Safety Recall Report 23V-488 Shortage status | We are collecting and organizing this information and may P2101396 02/2023 28 07-07-2021 Rosuvastatin 20 mg film-coated tablets PL 20075/0404 Batch Number Expiry Date Pack Size First Distributed P2003123A 03/2022 28 27-05-2021 P2101390 12/2022 28 27-06-2021 Rosuvastatin 40 mg film-coated tablets PL 20075/0405 Batch Number Expiry Date Pack Size First Distributed . See related recalls and warnings: Drugmaker Pfizer issued a voluntarily recall of three prescription blood pressure medications one name brand and two generics due to the presence of elevated levels of a potentially cancer-causing impurity. Cut III Heads for Jointers by BUSY BEE, Lux Cut III Heads for Planers by NORTHSTATE, Lux Cut III Heads for Jointers by YORKCRAFT, Lux Rosuvastatin comes as a tablet (Crestor) to take by mouth. endstream endobj 24 0 obj <>stream Description: Rosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count bottle NDC 16729-286-15, UPC 3 16729 28615 2; b) 1,000-count bottles NDC 16729-286-17, UPC 3 16729 28617 6; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Cut III Heads for Jointers by NORTHTECH, Lux Performance & security by Cloudflare. This includes notes The action you just performed triggered the security solution. Cut III Heads for Planers by YORKCRAFT. The .gov means its official.Federal government websites often end in .gov or .mil. Company Contact Information. 2023 ConsumerLab.com, LLC. Cut III Heads for Planers by CARBA TEC, Lux It belongs to a group of drugs . Six months later I needed a new hip and failed the pre op medical with bad kidney numbers - the surgeon said come back with good kidneys. Your doctor may order lab tests during your treatment, especially if you develop symptoms of liver damage. PDF How Supplied/Storage and Handling Patient Counseling Information Uses Warnings Before taking Dosage Side effects Interactions FAQ What is Crestor? Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way. Cut III Heads for Planers by NORTHWOOD, Lux Rosuvastatin: 7 things you should know - Drugs.com It is recommended to be used together with dietary changes, exercise, and weight loss. Your gift voucher discount has been applied. 3 Blood Pressure Medications Recalled by Pfizer - AARP This website is using a security service to protect itself from online attacks. FDA Recalls Enforcement Reports The last Recall Enforcement Report for Rosuvastatin with NDC 16729-286 was initiated on 02-07-2023 as a Class II recall due to cgmp deviations: recalling drug products following an fda inspection. Rosuvastatin comes only in the form of a tablet you take by mouth. Drug Recalls | FDA BACKGROUND: Statins are a class of prescription medicines that have been used for decades to lower low-density lipoprotein (LDL-C or "bad") cholesterol in the blood. See FDAs role in drug recalls for more information. CRESTOR (rosuvastatin) tablets, for oral use Initial U.S. Approval: 2003 ----- RECENT MAJOR CHANGES -----Contraindications, Pregnancy and Lactation (4) Removed 01/2023 Warnings and Precautions (5.2) 01/2023 Warnings and Precautions , Concomitant Coumarin Anticoagulants (5.4) Removed 01/2023 It is usually taken once a day with or without food. Rosuvastatin may harm the fetus. We are cannot paste into this field.Please re-type your Cloudflare Ray ID: 7ee9eb553ffd2366 Cut III Heads for Planers by TRANSPOWER, Lux You may also want to report the problem to the U.S. FDA through their Recall Enforcement Report D-0524-2023 - NDC List Do not stop taking rosuvastatin without talking to your doctor. We might test the product in the future. Cut III Heads for Jointers by SHOP FOX, Lux Multi event Drug Recall Enforcement Report Class II voluntary initiated by Preferred Pharmaceuticals, Inc., originally initiated on 03-23-2023 for the product Simvastatin Tablets, USP, 20 mg, Packaged as: a) 90-count bottle (NDC 68788-9869-9); b) 60-count bottle (NDC 68788-9869-6); c) 30-count bottle (NDC 68788-9869-3), Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703. per regular mail. Please complete the form below as accurately as possible. Download form or call 1-800-332-1088 to. - On July 7, 2023, having completed its investigation of the additional complaints, Tesla made a voluntary determination to recall the affected vehicles. Cut III Heads for Jointers by STEEL CITY, Lux Dosages and Precautions. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088). Rosuvastatin Market [ Statistical Data - MarketWatch What special precautions should I follow? March 23, 2022. Performance & security by Cloudflare. The American Society of Health-System Pharmacists, 4500 East-West Highway, Suite 900, Bethesda, Maryland. Pfizer launches a recall of blood pressure drugs due to a potential FDA expects removing the contraindication will enable health care professionals and patients to make individual decisions about benefit and risk, especially for those at very high risk of heart attack or stroke. Page Last Updated: March 13, 2023 Description: Rosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count bottle NDC 16729-286-15, UPC 3 16729 28615 2; b) 1,000-count bottles NDC 16729-286-17, UPC 3 16729 28617 6; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Cut III Heads for Jointers by GRIZZLY, Lux A contraindication is FDA's strongest warning and is only added when a medicine should not be used because the risk clearly outweighs any possible benefit. http://www.fda.gov/Safety/MedWatch/SafetyInformation, http://www.nhlbi.nih.gov/health/public/heart/chol/chol_tlc.pdf, American Society of Health-System Pharmacists, Inc. Disclaimer, U.S. Department of Health and Human Services. Please include what you were doing when this page came up and the Cloudflare Ray ID found at the bottom of this page. For recall notices older than 60 days, see recall and safety alerts archive. Warning: Five Leaf Pet Botanicals, Inc. Accord Healthcare Limited. Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. ROSUVASTATIN CALCIUM Recall D-0406-2023 - Product Safety Recalls Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA, 2022 Recall.Report / Contact / Privacy Policy. This website is using a security service to protect itself from online attacks. Recall Enforcement Report D-0502-2023 - NDC List Crestor (Rosuvastatin) Reviews | Everyday Health We might test the product in the future. Seller of CBD Tinctures, Creams & Pet Products Promoted for Pain, Cancer & More Warned by FDA Cut III Heads for Jointers by AMERICAN MACHINE TOOL, Lux Management action:Alternative generic products are available, Deletion from market: You may We present a case report of an 80-90-year-old man with coronary artery disease who rapidly developed severe rhabdomyolysis during treatment . The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. Cut III Heads for Planers by SHOP FOX, Lux Multi event Drug Recall Enforcement Report Class II voluntary initiated by RemedyRepack Inc., originally initiated on 03-20-2023 for the product Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-00), Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. No blood tests. Cut III Heads for Jointers by CENTRAL MACHINERY, Lux if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking rosuvastatin. Swallow the entire mixture immediately without chewing. Cut III Heads for Planers by BRIDGEWOOD, Lux Rhabdomyolysis can cause extreme muscle pain, liver damage, kidney failure and death. PDF Class 4 Notification - Caution in Use - Gov.uk The action you just performed triggered the security solution. Rosuvastatin is used together with diet, and alone or in combination with other medications, to decrease the amount of cholesterol and other fatty substances in the blood in adults and children and teenagers 7 to 17 years of age who have familial homozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally). Rosuvastatin Side Effects: Common, Severe, Long Term - Drugs.com . difficulty falling asleep or staying asleep, muscle pain, tenderness, or weakness (or if these symptoms continue after stopping rosuvastatin), dark, reddish urine; decreased amount of urine; weakness; and muscle aches, pain in the upper right part of the abdomen, swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs. Seller of NeuSilver Colloidal Silver for Adults, Children and Pets Warned by FDA. Your doctor will probably start you on a low dose of rosuvastatin and gradually increase your dose, not more than once every 2 to 4 weeks. The latest recall number for this product is D-0405-2023 and the recall is currently ongoing . You can email the site owner to let them know you were blocked. Atorvastatin oral tablet dosage and frequency will depend upon several factors, the most important being the medical condition it is being targeted for and the age of the patient. Heads, Set 23 Jun 2023, Availability:Reduction in supply until supply is exhausted, Deletion from market: Cut III Heads for Planers by KING CANADA, Lux What special dietary instructions should I follow? To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location one that is up and away and out of their sight and reach. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. This website is using a security service to protect itself from online attacks. You can also visit the National Cholesterol Education Program (NCEP) website for additional dietary information at http://www.nhlbi.nih.gov/health/public/heart/chol/chol_tlc.pdf. In case of overdose, call the poison control helpline at 1-800-222-1222. Talk to your doctor about birth control methods that you can use during your treatment. There are several actions that could trigger this block including submitting a certain word or phrase, a SQL command or malformed data. This medication may be prescribed for other uses; ask your doctor or pharmacist for more information. Do not take more or less of it or take it more often than prescribed by your doctor. Rosuvastatin-induced rhabdomyolysis: case report and call for proactive do not breastfeed while taking rosuvastatin. Shortage status: Current. email. Anonymous; Taken for 6 months to 1 year; August 12, 2019; Crestor (rosuvastatin) for High Cholesterol "My doctor switched me to Crestor because, he said, it is stronger, and he is a real cholesterol hound. Crestor (Rosuvastatin) Reviews 57 people have reviewed this drug Review this Drug SHOW: All Highest Lowest Posted 1 months ago (6/8/2023) Rated for High cholesterol Report Started crestor. Back to ALL shortages and discontinuationsBack to CRITICAL shortages and discontinuations. ROSUVASTATIN CALCIUM Recall D-0520-2023 Page Last Updated: April 14, 2023 Description: Rosuvastatin Tablets, USP, 5mg, 30-count bottle, Rx only, Manufactured: Accord Healthcare, Inc., Durham, NC 27703, NDC 68788-7971-3 ROSUVASTATIN CALCIUM Recall D-0520-2023 Information Cut III Heads for Jointers by POWERMATIC, Lux 178.128.5.87 Consumers: Inmar Rx Solutions, Inc. (855) 769-3988 / (855) 769-3989. CGMP Deviations: recalling drug products following an FDA inspection. Rosuvastatin works by blocking an enzyme in the liver called HMG-CoA reductase, which leads to the liver making less cholesterol. See Recalls, Market Withdrawals, & Safety Alertsfor all FDA-regulated products. The impurity, N-nitroso-quinapril, was found in six lots of Accuretic, one lot of the generic form of quinapril and . Cut III Heads for Jointers by INVICTA, Lux Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); colchicine (Colcrys); cimetidine (Tagamet); cyclosporine (Gengraf, Neoral, Sandimmune); darolutamide (Nubeqa); eltrombopag (Promacta); ketoconazole (Nizoral); other medications for high cholesterol such as fenofibrate (Tricor), gemfibrozil (Lopid), and niacin (Niaspan, Niacor); certain hepatitis C virus (HCV) medications including dasabuvir taken with ombitasvir, paritaprevir, and ritonavir (Viekira Pak); glecaprevir taken with pibrentasvir (Mavyret), ledipasvir taken with sofosbuvir (Harvoni), simeprevir (no longer available in US), or sofosbuvir taken with velpatasvir and/or voxilaprevir (Epclusa, Vosevi); certain HIV protease inhibitors including atazanavir (Reyataz) taken with ritonavir (Norvir), and lopinavir and ritonavir (Kaletra); regorafenib (Stivarga); and spironolactone (Aldactone). Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of All h0_ei&iAzXE :4eA=?I> d@@JALr#Hxxqq2f-@_A}Thbw`n<7i\joe49"&Z 00f^ k*0?AwyE%ZyEeRv}1?G@ M&t? = y Class 4 Medicines Defect Information, Rosuvastatin 5 mg, 10 mg, 20 mg Medicine Shortages Information Initiative | Therapeutic Goods Cut III Heads for Jointers by CARBATEC, Lux Because the benefits of statins may include prevention of serious or potentially fatal events in a small group of very high-risk pregnant patients, contraindicating these drugs in all pregnant women is not appropriate. Instead, the best way to dispose of your medication is through a medicine take-back program.

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