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  • 2020 Medical Device Recalls

    List of Medical Device recalls in 2020. [ Read more ]
  • Transliquid Technologies LLC Issues Voluntary Recall of Mystic Shield Protection Topical Solution Due to Presence of Undeclared Methanol for the States of California, Louisiana, Massachusetts, and Texas

    Transliquid Technologies LLC is voluntarily recalling all Mystic Shield Protection Topical Solution, manufactured by Mystic Intl S.A. de C.V in Mexico City, and packaged in an 8.45 ounce (250 ml) bottles, to the consumer level. [ Read more ]
  • Arrow International Inc. Recalls Arrow AutoCAT®2 and AC3 Optimus® IABP Series Due to Possible Breakdown of Motor Connector Wires

    Arrow International is recalling the pumps because both devices have a part that may break, char, and discolor the motor connector wires. [ Read more ]
  • UVT, INC. Issues Voluntary Nationwide Recall of SANIDERM ADVANCED HAND SANITIZER Due to the Potential Presence of Undeclared Methanol (Wood Alcohol)

    UVT, INC. is voluntarily recalling 38,830 liters of SANIDERM ADVANCED HAND SANITIZER, packaged in 1-liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol) [ Read more ]
  • Saniderm Products Voluntarily Issues Regional (Virginia, Maryland, New Jersey) Recall of 1 L Saniderm Advanced Hand Sanitizer bottles produced by Eskbiochem SA de CV Due to the Potential Presence of Undeclared Methanol (Wood Alcohol)

    Saniderm Products (Saniderm) is voluntarily recalling Saniderm Advanced Hand Sanitizer, packaged in 1-liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). In response to a recent news alert by the Food and Drug Administration [ Read more ]
  • Chengdu Ai Qin E-Commerce Co., Ltd Issues Nationwide Recall of TTDEYE Brand Colored Contact Lenses

    On June 18, 2020, Chengdu Ai Qin E-commerce Co., Ltd initiated a nationwide recall of 1362 pairs of colored contact lenses. The relevant series of contact lenses have been found to be distributed without FDA clearance and may pose a threat to health. [ Read more ]
  • Certain COVID-19 Serology/Antibody Tests Should Not Be Used - Letter to Clinical Laboratory Staff and Health Care Providers

    FDA warns lab staff and health care providers about using certain COVID-19 Serology/Antibody Tests. [ Read more ]
  • GSK Consumer Healthcare Issues Voluntary Nationwide Recall of Children's Robitussin® Honey Cough and Chest Congestion DM and Children's Dimetapp® Cold and Cough Due to Dosing Cups Missing Some Graduation Markings

    GSK Consumer Healthcare is voluntarily recalling to the retail level two lots (listed below) of Children’s Robitussin® Honey Cough and Chest Congestion DM and one lot of Children’s Dimetapp® Cold and Cough, due to the inclusion of incorrect dosing cups. [ Read more ]
  • Remdesivir by Gilead Sciences: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of Treatment

    FDA is warning health care providers that co-administration of remdesivir and chloroquine phosphate or hydroxychloroquine sulfate is not recommended as it may result in reduced antiviral activity of remdesivir. [ Read more ]
  • Lupin Pharmaceuticals, Inc. Issues Voluntarily Nationwide Recall of One Lot of Metformin Hydrochloride Extended-Release Tablets USP, 500mg Due to the Detection of N-Nitrosodimethylamine (NDMA)

    Lupin Pharmaceuticals Inc. is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets USP (generic equivalent of Fortamet®), 500mg, lot G901203 to the consumer level. FDA analysis revealed that this lot exceeded the Acceptable Daily Intake Limit for the impurity N-Nitrosodimethylamine [ Read more ]
  • Certain Filtering Facepiece Respirators from China May Not Provide Adequate Respiratory Protection - Letter to Health Care Providers

    The FDA is concerned that certain respirators from China may not provide adequate protection to health care personnel based on testing by CDC NIOSH. [ Read more ]
  • Use the Correct Cycle and Compatible N95 Respirators When Decontaminating Respirators with STERRAD Sterilization Systems - Letter to Health Care Providers

    The FDA is reminding reprocessing staff in health care facilities to use the correct decontamination cycle associated with certain models of the ASP STERRAD Sterilization Systems to decontaminate compatible NN95 respirators. [ Read more ]
  • Teva Pharmaceuticals USA, Inc. Initiates Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP 500 mg and 750 mg Due to Detection of N-Nitrosodimethylamine (NDMA)

    Teva Pharmaceuticals USA, Inc. is voluntarily recalling fourteen (14) lots of Metformin Hydrochloride Extended-Release Tablets, USP 500 mg and 750 mg, 100 and 1000 count bottles, in the United States to the consumer-level due to the detection of N-Nitrosodimethylamine (NDMA) levels in excess of the [ Read more ]
  • Apotex Corp. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets 500mg Due to the Detection of N-nitrosodimethylamine (NDMA)

    Apotex Corp is voluntarily recalling all lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg within expiry to retail level. Apotex was notified by the U.S. Food and Drug Administration (US FDA) that one lot of Metformin Hydrochloride Extended-Release Tablets, USP was tested and showe [ Read more ]
  • Marksans Pharma Limited Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets, USP 500mg, Due to the Detection of N-Nitrosodimethylamine (NDMA)

    Marksans Pharma Limited, India is voluntarily recalling Metformin Hydrochloride Extended-Release Tablets, USP 500mg, lot # XP9004, to the consumer level. FDA analysis has found the product to contain N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) of 96ng/da [ Read more ]
FDA Press Releases RSS Feed
  • Coronavirus (COVID-19) Update: FDA Authorizes Additional COVID-19 Combination Diagnostic Test Ahead of Flu Season

    The FDA has issued an EUA for another combination diagnostic that can test for flu and COVID-19 to prepare for this upcoming flu season. [ Read more ]
  • FDA Approves New HIV Treatment for Patients With Limited Treatment Options

    FDA approved Rukobia (fostemsavir), a new antiretroviral medication for adult patients with HIV who have tried multiple HIV medications and whose HIV infection cannot be successfully treated with other therapies because of resistance, intolerance or safety considerations. [ Read more ]
  • Coronavirus (COVID-19) Update: Daily Roundup July 2, 2020

    Coronavirus (COVID-19) Update: Daily Roundup [ Read more ]
  • Coronavirus (COVID-19) Update: FDA Takes Action to Warn, Protect Consumers from Dangerous Alcohol-Based Hand Sanitizers Containing Methanol

    FDA is warning consumers and health care professionals about hand sanitizer products containing methanol, or wood alcohol that is dangerous and not an acceptable active ingredient for hand sanitizer products. [ Read more ]
  • Coronavirus (COVID-19) Update: Daily Roundup July 1, 2020

    Coronavirus (COVID-19) Update: Daily Roundup [ Read more ]
  • Coronavirus (COVID-19) Update: Daily Roundup June 30, 2020

    Coronavirus (COVID-19) Update: Daily Roundup [ Read more ]
  • Coronavirus (COVID-19) Update: FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines

    The FDA is taking important action to help facilitate the timely development of safe and effective vaccines to prevent COVID-19 by providing guidance with recommendations for those developing COVID-19 vaccines. [ Read more ]
  • Coronavirus (COVID-19) Update: Daily Roundup June 29, 2020

    Coronavirus (COVID-19) Update: Daily Roundup [ Read more ]
  • FDA Approves First-Line Immunotherapy for Patients with MSI-H/dMMR Metastatic Colorectal Cancer

    FDA approves Keytruda for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. [ Read more ]
  • FDA Approves Breast Cancer Treatment That Can Be Administered At Home By Health Care Professional

    FDA approves Phesgo to treat adult patients with HER2-positive breast cancer. Phesgo can be administered at home by a health care professional once chemotherapy is finished. [ Read more ]
  • Coronavirus (COVID-19) Update: Daily Roundup June 26, 2020

    Coronavirus (COVID-19) Update: Daily Roundup [ Read more ]
  • FDA Approves New Therapy for Dravet Syndrome

    FDA approves Fintepla (fenfluramine), a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in patients age 2 and older. Dravet syndrome is a life-threatening, rare and chronic form of epilepsy. [ Read more ]
  • Coronavirus (COVID-19) Update: Daily Roundup June 25, 2020

    Coronavirus (COVID-19) Update: Daily Roundup [ Read more ]
  • Coronavirus (COVID-19) Update: Daily Roundup June 24, 2020

    Coronavirus (COVID-19) Update: Daily Roundup [ Read more ]
  • Coronavirus (COVID-19) Update: Joint Statement from USDA and FDA on Food Export Restrictions Pertaining to COVID-19

    U.S. Secretary of Agriculture Sonny Perdue and FDA Commissioner Stephen M. Hahn, M.D., issued the following statement regarding food export restrictions pertaining to COVID-19. [ Read more ]
Food and Drugs Administration--Recalls/Safety Alerts
  • The J. M. Smucker Company Issues Voluntary Recall of One Lot of Natural Balance® Ultra Premium Chicken & Liver Paté Formula Canned Cat Food

    The J. M. Smucker Company today announced a voluntary recall of one lot of Natural Balance® Ultra Premium Chicken & Liver Paté Formula canned cat food due to health concerns likely associated with elevated levels of choline chloride. [ Read more ]
  • Jewel-Osco Voluntarily Recalls Bagged Signature Farms Garden Salad Due to Possible Cyclospora Contamination

    In cooperation with the Fresh Express recall of bagged salads potentially linked to an outbreak of Cyclospora infections in the Midwest, Jewel-Osco is voluntarily recalling bagged Signature Farms Garden Salad sold in its stores in Illinois, Indiana, and Iowa. [ Read more ]
  • Transliquid Technologies LLC Issues Voluntary Recall of Mystic Shield Protection Topical Solution Due to Presence of Undeclared Methanol for the States of California, Louisiana, Massachusetts, and Texas

    Transliquid Technologies LLC is voluntarily recalling all Mystic Shield Protection Topical Solution, manufactured by Mystic Intl S.A. de C.V in Mexico City, and packaged in an 8.45 ounce (250 ml) bottles, to the consumer level. [ Read more ]
  • Garland Ventures LTD Voluntary Recalls Five Cheese Stuffed Shells Because of Possible Health Risk

    Garland Ventures Ltd of Garland, Texas is voluntary recalling 1095 cases of Five Cheese Stuffed Shells trays because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, [ Read more ]
  • UVT, INC. Issues Voluntary Nationwide Recall of SANIDERM ADVANCED HAND SANITIZER Due to the Potential Presence of Undeclared Methanol (Wood Alcohol)

    UVT, INC. is voluntarily recalling 38,830 liters of SANIDERM ADVANCED HAND SANITIZER, packaged in 1-liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol) [ Read more ]
  • Salad Supplier Recall Expanded after Potential Cyclospora Contamination; Hy-Vee Pulls Additional Salads as a Result

    Hy-Vee, Inc., based in West Des Moines, Iowa, is recalling an additional 12 salads across its eight-state region due to the potential that they may be contaminated with Cyclospora. [ Read more ]
  • Allergy Alert for Undeclared Tree Nut in Red Velvet Cheesecake Slices Issued by Whole Foods Market Stores in California, Idaho, and Nevada

    Whole Foods Market is voluntarily recalling Red Velvet Cheesecake Slices from 36 stores in California, Boise, Idaho, and Reno, Nevada, due to an undeclared tree nut (walnut) allergen. [ Read more ]
  • Norpac Fisheries Export Recalls Shrimp Poke Due to Possible Health Risk

    Norpac Fisheries Export is recalling all fresh shrimp poke distributed in the Hawaiian Island between May 11, 2020 and June 25, 2020 because it has potential to be contaminated with Listeria monocytogenes [ Read more ]
  • Fresh Express Issues a Precautionary Recall of Products Containing Iceberg, Red Cabbage and Carrots Produced at its Streamwood, IL Facility Due to a Potential Cyclospora Risk

    Fresh Express, out of an abundance of caution, has issued a voluntary recall of branded and private label salad products produced at its Streamwood, IL facility that contain iceberg lettuce, red cabbage and/or carrot ingredients due to a possible health risk from Cyclospora. According to the Centers [ Read more ]
  • Saniderm Products Voluntarily Issues Regional (Virginia, Maryland, New Jersey) Recall of 1 L Saniderm Advanced Hand Sanitizer bottles produced by Eskbiochem SA de CV Due to the Potential Presence of Undeclared Methanol (Wood Alcohol)

    Saniderm Products (Saniderm) is voluntarily recalling Saniderm Advanced Hand Sanitizer, packaged in 1-liter bottles to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol). In response to a recent news alert by the Food and Drug Administration [ Read more ]
  • Fresh Express Voluntarily Issues Recall of Limited Quantity of Marketside Classic Iceberg Salad

    Fresh Express, out of an abundance of caution, has issued a recall of a limited quantity of Marketside Classic Iceberg Salad from select stores as a precautionary measure due to a possible health risk from Cyclospora. [ Read more ]
  • Chengdu Ai Qin E-Commerce Co., Ltd Issues Nationwide Recall of TTDEYE Brand Colored Contact Lenses

    On June 18, 2020, Chengdu Ai Qin E-commerce Co., Ltd initiated a nationwide recall of 1362 pairs of colored contact lenses. The relevant series of contact lenses have been found to be distributed without FDA clearance and may pose a threat to health. [ Read more ]
  • Beyond Better Foods, LLC Issues Allergy Alert on Undeclared Milk in Mislabeled Chocolate Peanut Butter Pints

    Beyond Better Foods, LLC, is recalling select pints from a single production run of Enlightened brand Chocolate Peanut Butter ice cream pints because they may have been packaged in Dairy-Free Chocolate Peanut Butter containers and thus contain undeclared milk ingredients [ Read more ]
  • In Association with Fresh Express Inc., ALDI Voluntarily Recalls Little Salad Bar Garden Salad

    In cooperation with Fresh Express Inc., and out of an abundance of caution, ALDI has removed Little Salad Bar Garden Salad from select stores as a precautionary measure due to possible Cyclospora infection. [ Read more ]
  • Mount Franklin Foods, LLC dba Azar Nut Company Issues Allergy Alert on Undeclared Peanuts in “7-Select Yogurt Pretzels”

    Mount Franklin Foods, LLC dba Azar Nut Company of El Paso, TX is voluntarily recalling its 5-ounce packages of "7-Select Yogurt Pretzels" because they may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life- threatening allergic reaction if they consume t [ Read more ]
What's New: Drugs RSS Feed
  • Transliquid Technologies LLC Issues Voluntary Recall of Mystic Shield Protection Topical Solution Due to Presence of Undeclared Methanol for the States of California, Louisiana, Massachusetts, and Texas

    Transliquid Technologies LLC is voluntarily recalling all Mystic Shield Protection Topical Solution, manufactured by Mystic Intl S.A. de C.V in Mexico City, and packaged in an 8.45 ounce (250 ml) bottles, to the consumer level. [ Read more ]
  • FDA Approves New HIV Treatment for Patients With Limited Treatment Options

    FDA approved Rukobia (fostemsavir), a new antiretroviral medication for adult patients with HIV who have tried multiple HIV medications and whose HIV infection cannot be successfully treated with other therapies because of resistance, intolerance or safety considerations. [ Read more ]
  • What's New Related to Drugs

    Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc. [ Read more ]
  • Topical Drug Development Workshop - Evolution of Science and Regulatory Policy 2 - 07/23/2020 - 07/24/2020

    Virtual public Workshop [ Read more ]
  • FDA Updates and Press Announcements on NDMA in Metformin

    FDA Updates and Press Announcements on NDMA in Metformin [ Read more ]
  • FDA Updates on Hand Sanitzers with Methanol

    FDA Warns consumers and healthcare professionals of Hand Sanitizers contaminated with Methanol [ Read more ]
  • La FDA aconseja a los consumidores no usar productos para desinfectar manos que hayan sido fabricados por Eskbiochem

    La FDA advierte a los consumidores no usar ningún desinfectante para manos fabricado por Eskbiochem SA de CV de México, debido a la posibilidad de que contengan metanol (alcohol de madera), el cual es una sustancia que puede ser tóxica cuando se absorbe por la piel o se ingiere. La FDA ha identifica [ Read more ]
  • FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch

    [06-02-2016] The U.S. Food and Drug Administration (FDA) is investigating the risk of serious burns and potential permanent scarring with the use of Zecuity (sumatriptan iontophoretic transdermal system) patch for migraine headaches. [ Read more ]
  • Compounding: Inspections, Recalls, and other Actions

    Human drug compounding; FDA inspections; compounding recalls [ Read more ]
  • Coronavirus (COVID-19) Update: Daily Roundup July 1, 2020

    Coronavirus (COVID-19) Update: Daily Roundup [ Read more ]
  • Drug Safety Communications

    FDA Drug Safety Communications connect consumers and health care professionals to important drug safety information. The webpage contains the most recent Drug Safety Communications from FDA as well as links for Early Communications, Follow-Up Early Communications, Information for Healthcare Professional sheets, and Public Health Advisories issued prior to January 29th, 2010. [ Read more ]
  • Q&A for Consumers: Hand Sanitizers and COVID-19

    Find information and answers to frequently asked questions about hand sanitizers and COVID-19 [ Read more ]
  • UPDATED AGENDA AND PUBLIC PARTICIPATION INFORMATION: June 17-18, 2020: Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (pedsODAC) - 06/17/2020 - 06/18/2020

    June 17-18, 2020: Meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee (pedsODAC) [ Read more ]
  • UPDATED PUBLIC PARTICIPATION INFORMATION: December 17, 2019: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement - 12/17/2019 - 12/17/2019

    UPDATED PUBLIC PARTICIPATION INFORMATION: December 17, 2019: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement [ Read more ]
  • Clinical Outcome Assessments (COA) Qualification Submissions

    Clinical Outcome Assessments (COA) Qualification Submissions [ Read more ]
Whats New Vaccines Blood Biologics RSS Feed
  • Flublok Quadrivalent

    Flublok Quadrivalent is a vaccine indicated for active immunization against disease caused by influenza A subtype viruses and influenza type B viruses contained in the vaccine. Flublok Quadrivalent is approved for use in persons 18 years of age and older. [ Read more ]
  • What’s New for Biologics

    Latest news from the Center for Biologics Evaluation and Research [ Read more ]
  • Fluarix Quadrivalent

    For active immunization of persons 6 months and older for the prevention of disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. [ Read more ]
  • Coronavirus (COVID-19) | CBER-Regulated Biologics

    This page and the associated links provide information on guidance and advice relevant to the development of therapies to treat or prevent COVID-19, and contact information for developers seeking additional information or assistance. [ Read more ]
  • Fluzone Quadrivalent

    For active immunization of persons 6 months of age and older for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. [ Read more ]
  • Influenza Virus Vaccine Composition and Lot Release

    Influenza Virus Vaccine Composition and Lot Release [ Read more ]
  • AFLURIA QUADRIVALENT

    For active immunization of persons ages 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. [ Read more ]
  • Evaluation of Therapeutic Approaches Based on Genome Editing and Stem Cell Technologies

    Zhaohui Ye's research project "Evaluation of Therapeutic Approaches Based on Genome Editing and Stem Cell Technologies". [ Read more ]
  • Infectious Disease Tests

    Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays [ Read more ]
  • Tissue Safety & Availability

    Tissue Safety & Availability [ Read more ]
  • Tissue & Tissue Products

    CBER regulates human cells or tissue intended for implantation, transplantation, infusion, or transfer into a human recipient is regulated as a human cell, tissue, and cellular and tissue-based product or HCT/P. [ Read more ]
  • Blood Donor Screening

    To protect patients from unsuitable blood and blood products, the FDA has required blood donors to answer specific questions about risk factors that could affect the safety of the donation. FDA requires blood centers to maintain lists of unsuitable donors to prevent further donations from these individuals and that blood is tested for several infectious agents after donation. All tests must be negative before the blood is suitable for transfusion. The agency also inspects all blood facilities at least every two years. [ Read more ]
  • 510(k) Process (CBER)

    510(k) Process (CBER) [ Read more ]
  • Cellular & Gene Therapy Products

    CBER provides oversight of clinical studies, proactive scientific and regulatory advice to medical researchers and manufacturers of cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. [ Read more ]
  • Testing Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P): Specific Requirements

    These are the Specific Requirements for Testing Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) [ Read more ]

News & Events

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