New Drug Application (NDA): 214621 Company: MYOVANT SCIENCES . Paul Gleason, PhD. The recall involves 31 different over-the-counter drugs purchased on or after June 1, 2018 that are unexpired from the following brands: Medi-First, Medi-First Plus, Medique, Dover, Otis Clapp, and Ecolab. NOTE: This is not a complete list of all recalls. Recall Came More Than a Year After an FDA Lamictal Safety Warning In April 2018, the FDA warned that Lamictal could cause a rare but serious reaction that could result in a potentially fatal autoimmune response. These lawsuits claim drug makers knew the NDMA in ranitidine could increase the risk of cancer but did not warn the public. Email; Products on NDA 214103 Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS; OXLUMO: LUMASIRAN SODIUM: EQ … Email; Products on NDA 214621 Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS; ORGOVYX: RELUGOLIX: 120MG: … Fresenius Kabi Issues Voluntary Nationwide Recall of 13 Lots of Ketorolac Tromethamine Injection, USP Due to the Presence of Particulate Matter in Reserve Samples . Drugs@FDA: FDA-Approved Drugs. FDA issues food recall after 28 dogs reportedly die from toxin Recall targets certain Sportmix products manufactured by Midwestern Pet Foods. Top News Videos for fda drug recall 2020. FDA Issues Guidance to Control NDMA in Zantac, Other Drugs Michelle Llamas October 6, 2020. Audience: Consumer, Health Professional, Pharmacy. Linkedin; Pin it; Email; Print ; Home | Previous Page. December 10, 2020. The medical device recall came after the company reported receiving more complaints than usual about the device’s tip becoming detached. FDA Recalls A Pair of Drugs Due to a Packaging Mix-Up. The .gov means it’s official. FDA Approves First New Mesothelioma Treatment in 16 Years Michelle Llamas October 6, 2020. Drug Recall List Last Updated: November 2020 Drug Recall Details Contact Date Drug Recall Class* Lansoprazole Delayed-Release Orally Disintegrating Tablets 06838277177 Failed Dissolution Specifications If you have questions about this recall… Linkedin; Pin it; Email; Print ; Home | Previous Page. FDA asks drugmakers to recall several diabetes drugs over contaminants By Associated Press. New Drug Application (NDA): 213687 Company: ULTRAGENYX PHARM INC . Paul Gleason, PhD . The United States Food and Drug Administration (FDA) has announced a nationwide recall of 2 drugs: sildenafil and trazodone. Food and Drug Administration announced Monday. April 20, 2020 -- Fresenius Kabi USA, LLC is voluntarily recalling 13 lots of Ketorolac … After the recalls people filed Zantac lawsuits against Sanofi and Pfizer, the drug’s manufacturers and marketers. FDA gives E-coli warning for romaine lettuce. As of February 2019, at least 140 … They include aspirin-containing products, acetaminophen-containing products, ibuprofen-containing products, lidocaine-containing products, diphenhydramine, loperamide, and … Please see FDA.gov >Drugs>Drug Safety and Availability> Drug Recalls for additional information. New Drug Application (NDA): 214103 Company: ALNYLAM PHARMS INC . Top Searches Holiday Gifts. Federal government websites often end in .gov or .mil. Drug recall alert In May 2020, the FDA issued a recall for metformin. 2 days ago. By Dawn Geske 11/03/20 AT 12:35 PM. Email; Products on NDA 213687 Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS; DOJOLVI: TRIHEPTANOIN: … Diabetes Drug Recall 2020: New Metformin Warning Issued Over Cancer Concerns . WLS – Chicago … As of March 27, 2020, more than a dozen manufacturers had recalled ranitidine products in the United States. The recall involves packages with with a packed on date of 10/15/2020 or 10/16/2020 with the UPC number 0-27918-20314-9. FDA Issues Warning on ‘Benadryl Challenge’ Michelle Llamas September 29, 2020… Recall alert: Drug company recalls medication due to drug mix-up Share By: Natalie Dreier, Cox Media Group National Content Desk Updated: December 10, 2020 - 1:37 PM The FDA reported the first drug shortage due to COVID-19 disruptions on February 28, but declined to identify the specific generic drug. Product Quality Review(s) (PDF) Multi-Discipline Review (PDF) … Earlier this month, it was extended to additional manufacturers, forms, and dosages. Next 228 results. [10/15/2020] - Drug Safety Communication - FDA] Source: FDA. Approval Letter(s) (PDF) Printed Labeling (PDF) FDA Application Review Files. Sildenafil and trazodone were inadvertently bottled together, posing serious health risks to consumers. Date: Jan 4, 2021 Recall: Metformin HCI Extended Release Tablets Details: Nostrum Laboratories, Inc. is recalling one lot of Metformin HCl Extended Release Tablets - USP, 750 mg (generic equivalent to Glucophage Tablets) because the tablets have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as published in the FDA Guidance Document issued September, 2020. Share; Tweet; Linkedin; Pin it; More sharing options. Recall List: Major Medical Device & Drug Safety Alerts of 2020 Michelle Llamas January 5, 2021. Sildenafil is the active ingredient in … Share; Tweet; Linkedin; Pin it; More sharing options. 00:27. 1-888-info-fda (1-888-463-6332) Contact FDA Subscribe to FDA RSS feeds Follow FDA on Twitter Follow FDA on Facebook View FDA videos on YouTube View FDA photos on Flickr List of Medical Device recalls in 2020. Linkedin; Pin it; Email; Print ; Home | Previous Page. Approval Date: 8/5/2020 Drugs@FDA information available about BLENREP. Drugs@FDA: FDA-Approved Drugs. 1 month ago. bag TC3 29... 12 3 4 5. Drugs@FDA: FDA-Approved Drugs. 6 months ago. Two lots of a widely used type 2 diabetes medication, metformin, are being recalled due to possible contamination with a potentially cancer-causing compound. Share; Tweet; Linkedin; Pin it; More sharing options. 2 years ago. Drugs@FDA: FDA-Approved Drugs. The … Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. Share; Tweet; Linkedin; Pin it; More sharing options. Over the course of 2020, several large-scale recalls of medical devices, supplies and drugs … Email; Products on NDA 213721 Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS; GAVRETO: PRALSETINIB: 100MG: … Old Glory Hearty Turkey and Cheese Flavor Dog Food UPC 0-70155-14297-9 – 12.75 lb. * Drugs@FDA includes information about drugs, including biological products, approved for human use in the United States (see FAQ), but does not include information about FDA-approved products regulated by the Center for Biologics Evaluation and Research (for example, vaccines, allergenic products, blood and blood products, plasma derivatives, cellular and gene therapy … The Food and Drug Administration (FDA) this month requested that the makers of Belviq and Belviq XR voluntarily withdraw the products from U.S. shelves after finding evidence they raised the risk of lung, colon and pancreatic cancers. Apr 20, 2020. Here's what to … Metformin was previously uncovered to … Linkedin; Pin it; Email; Print ; Home | Previous Page. “Essential devices are those that … FDA Publish Date:April 13, 2020 Company Announcement Date: January 25, 2018 -- Primus Pharmaceuticals, Inc. of Scottsdale, Arizona is voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level at FDA's request. Trending. The Food and Drug Administration has expanded the list of hand … FDA Approval Letter and Labeling. New Drug Application (NDA): 213721 Company: BLUEPRINT MEDICINES . Check your kitchen: The Food and Drug Administration (FDA) has announced three recalls affecting baby spinach, fresh organic basil and cut vegetables sold by … Medical device and drug recalls, whether voluntary or mandated by the FDA, ensure patient safety. Now, the U.S. Food and Drug Administration (FDA) is upgrading the recall to a Class I, which is the most serious classification of recall. FDA has requested a recall of Limbrel due to rare but serious and reversible side effects associated with Limbrel. 1 Cassie Scerbo; 2 Mitch McConnell; 3 Megan Thee Stallion; 4 Crede Bailey; 5 Edible Arrangements; 6 Jeff Bridges; 7 Contractor Liability Insurance; 8 Photo Blankets; 9 Keyontae Johnson; 10 COVID-19 … En español | The recall of a pair of weight loss drugs could have consumers worried about cancer, but experts say those risks appear to be small.. FDA Commissioner Stephen Hahn said at the time that his agency had identified 63 manufacturers with a total of 72 facilities that manufacture essential medical devices and was in contact with all of them. No other products or pack dates are being recalled. In February 2020, Boston Scientific announced a recall of Imager II 5F Angiographic Catheters. 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