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  • Fusion Health and Vitality Issues Voluntary Nationwide Recall of Core Essential Nutrients and Immune Boost Sublingual Vitamin D3 Due to the Unapproved Use of a Food Additive and Unapproved Marketing Statements

    Fusion Health and Vitality LLC is voluntarily recalling all 2020 Lots of CORE essential nutrients and Immune Boost Sublingual Vitamin D3. CORE has been found to contain an unapproved food additive, hordenine HCl, rendering it adulterated. Immune Boost Labeling was found to contain statements that [ Read more ]

  • Fresenius Kabi Issues Voluntary Nationwide Recall of a Single Lot of Dexmedetomidine Hydrochloride Injection Due to Cross-Contamination of Lidocaine

    Fresenius Kabi USA is voluntarily recalling a single lot of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg /mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to a trace amount of lidocaine present in the lot. This recall is being performed to the [ Read more ]

  • 2020 Medical Device Recalls

    List of Medical Device recalls in 2020. [ Read more ]

  • Cook Medical Recalls Fixed Core Wire Guides, Due to Device Damage from a Manufacturing Error

    The Cook Fixed Core Wire Guide is a curved wire guide made of stainless steel with non-reactive coating and helps insert medical devices into the body. [ Read more ]

  • Lohxa LLC Issues Voluntary Nationwide Recall of Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

    Lohxa, LLC is voluntarily recalling Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free (NDC:70166-027-15) products bearing an expiration date from 01/31/21 – 03/31/21 (see specific lots below) to the consumer level. This product is sourced and repackaged from Sunstar Americas Inc. who has no [ Read more ]

  • Stryker Neurovascular Recalls Trevo XP ProVue Retriever Due to Core Wire That May Break or Separate During Use

    Stryker Neurovascular Recalls Trevo XP ProVue Retriever Due to Core Wire That May Break or Separate During Use [ Read more ]

  • Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 500 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

    Nostrum Laboratories, Inc. is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 500 mg to the consumer level. The Metformin HCl Extended Release Tablets, USP 500 mg have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as publish [ Read more ]

  • Medtronic Recalls Rashkind Balloon Septostomy Catheters for Quality Issues

    Medtronic Recalls Rashkind Balloon Septostomy Catheters for Quality Issues [ Read more ]

  • Potential for False Positive Results with Antigen Tests for Rapid Detection of SARS-CoV-2 - Letter to Clinical Laboratory Staff and Health Care Providers

    Laboratories should expect some false positive results when screening large populations with a low prevalence of COVID-19 infection. [ Read more ]

  • Nostrum Laboratories, Inc. Issues Voluntary Nationwide Recall of Metformin HCl Extended Release Tablets, USP 750 mg, Due to N-Nitrosodimethylamine (NDMA) Content Above the Acceptable Daily Intake (ADI) Limit

    Kansas City, Missouri, Nostrum Laboratories, Inc. is voluntarily recalling 2 (two) lots of Metformin HCl Extended Release Tablets, USP 750 mg to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg have been found to contain levels of nitrosamine impurities above the ADI limit [ Read more ]

  • Baxter Issues Urgent Device Correction to Reinforce Important Safety Information Regarding Cleaning Practices of all Sigma Spectrum Infusion Pumps (V6, V8 and IQ)

    Baxter International Inc. announced today it has issued an Urgent Device Correction to reinforce important safety information regarding cleaning practices of all Spectrum infusion pumps distributed in the United States, Canada, and the Caribbean, as deviations from the specified cleaning methods may [ Read more ]

  • Sunstar Americas Inc. Issues Voluntary Nationwide Recall of Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

    Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 6/30/22 – 9/30/22 (see specific lots below) to the consumer level. This product may be contaminated with the bacteria Burkholderia lata. [ Read more ]

  • Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Drug Safety Communication - Avoid Use of NSAIDs in Pregnancy at 20 Weeks or Later

    FDA is warning that use of NSAIDs around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby. This can lead to low levels of amniotic fluid surrounding the baby and possible complications. [ 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 ]

  • Recommendations on Providing Clear Instructions to Patients Who Self-Collect an Anterior Nares (Nasal) Sample in a Health Care Setting for SARS-CoV-2 Testing - Letter to Health Care Providers

    FDA's recommendations to health care providers on giving instructions to patients who self-collect an anterior nares sample for SARS-CoV-2 testing. [ Read more ]
FDA Press Releases RSS Feed

  • Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Second COVID-19 Vaccine Candidate

    FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 17, 2020 to discuss Moderna’s emergency use authorization request for a COVID-19 vaccine. [ Read more ]

  • Coronavirus (COVID-19) Update: FDA Issues New Policy on Dry Heat for Reuse of Certain Respirators

    The FDA issued guidance on the use of dry heat for bioburden reduction to help support the single-user reuse of certain particulate filtering facepiece respirators (FFRs), such as N95 respirators, by health care personnel when there is a limited supply during the COVID-19 public health emergency. [ Read more ]

  • Coronavirus (COVID-19) Update: November 24, 2020

    Coronavirus (COVID-19) Update [ Read more ]

  • FDA Approves First Drug to Treat Rare Metabolic Disorder

    Today, the FDA approved the first treatment for primary hyperoxaluria type 1 (PH1), a rare genetic disorder which causes recurrent kidney stones and loss of kidney function. [ Read more ]

  • Coronavirus (COVID-19) Update: November 23, 2020

    Coronavirus (COVID-19) Update, November 23, 2020 [ Read more ]

  • FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention

    Today, the FDA expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza (flu) for patients 12 years of age and older after contact with an individual who has the flu. [ Read more ]

  • Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19

    Today, the FDA issued an emergency use authorization for two monoclonal antibodies to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients who are at high risk for progressing to severe COVID-19. [ Read more ]

  • Coronavirus (COVID-19) Update: November 20, 2020

    Coronavirus (COVID-19) Update [ Read more ]

  • FDA Approves First Treatment for Hutchinson-Gilford Progeria Syndrome and Some Progeroid Laminopathies

    Today, the U.S. Food and Drug Administration approved Zokinvy (lonafarnib) capsules to reduce the risk of death due to Hutchinson-Gilford Progeria Syndrome and for the treatment of certain processing-deficient progeroid laminopathies in patients one year of age and older. [ Read more ]

  • Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate

    FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10, 2020 to discuss Pfizer and BioNTech’s emergency use authorization request for a COVID-19 vaccine. [ Read more ]

  • Coronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19

    Today, the FDA issued an emergency use authorization for the drug baricitinib, in combination with remdesivir, for the treatment of COVID-19 in hospitalized adults and pediatric patients 2+ years requiring supplemental oxygen, invasive mechanical ventilation, or ECMO. [ Read more ]

  • FDA Releases New Outbreak Investigation Table

    FDA releases new tool to communicate foodborne illness outbreak information frequently and as soon as the FDA begins an outbreak investigation. [ Read more ]

  • Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home

    The FDA issued an emergency use authorization for the first COVID-19 diagnostic test that allows for self-collection and testing at home and provides test results in 30 minutes or less. [ Read more ]

  • Coronavirus (COVID-19) Update: November 17, 2020

    Coronavirus (COVID-19) Update [ Read more ]

  • COVID-19 Update: FDA’s Ongoing Commitment to Transparency for COVID-19 EUAs

    FDA is committed to transparency around the EUA process [ Read more ]
Food and Drugs Administration--Recalls/Safety Alerts

  • Vegpro International Issues a Recall of Fresh Attitude Baby Spinach Because of Potential Salmonella Health Risk

    Vegpro International of Sherrington, QC CAN is recalling Fresh Attitude baby spinach (5oz and 11oz) with Best before dates of Dec 4th (for 11oz) and Dec 4th & 5th (for the 5oz), because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal [ Read more ]

  • Prairie Farms Issues Allergy Alert on Undeclared Egg in Chocolate Milk Gallons

    Prairie Farms has issued a limited voluntary recall of its Prairie Farms Premium Flavored Chocolate Milk gallons and Prairie Farms 1% Lowfat Chocolate Milk gallons (Best by Date: Dec. 4, 2020) that were not labeled for an egg allergen that may be present. People who have an allergy or severe sensit [ Read more ]

  • Shenandoah Growers Inc Issues a Limited, Voluntary Recall of Certain Imported Organic Basil Because of Potential Health Risk

    Shenandoah Growers, Inc (Harrisonburg, VA) out of an abundance of caution, has issued a limited, voluntary recall of approximately 15,000 units in select packages, due to a possible health risk from Cyclospora. [ Read more ]

  • Hy-Vee Voluntarily Recalls Two Short Cuts Vegetable Mix Products Because of Possible Health Risk

    Hy-Vee, Inc., based in West Des Moines, Iowa, is voluntarily recalling two of its Hy-Vee Short Cuts vegetable mix products across its eight-state region (IL, IA, KS, MN, MO, NE, SD, and WI) due to possible contamination with Listeria monocytogenes. The potential for contamination was discovered duri [ Read more ]

  • Riverside Natural Foods LTD. Issues Allergy Alert on Undeclared Almond in "Good & Gather Banana Chocolate Chip Date & Nut Bar"

    Riverside Natural Foods, of Vaughan, ON is voluntarily recalling its 8 ounce packages of " Good & Gather Banana Chocolate Chip Date & Nut Bar " because they were improperly labelled and may contain undeclared almonds. The product is labelled to may contain tree nuts; however, people who have allergi [ Read more ]

  • Allergy Alert Issued for Undeclared Shrimp in Mislabeled Popcorn Chicken from 26 Whole Foods Market Stores

    Whole Foods Market is voluntarily recalling packaged popcorn chicken with sweet chili sauce across 26 stores in Northern California and Reno, Nevada. [ Read more ]

  • Fusion Health and Vitality Issues Voluntary Nationwide Recall of Core Essential Nutrients and Immune Boost Sublingual Vitamin D3 Due to the Unapproved Use of a Food Additive and Unapproved Marketing Statements

    Fusion Health and Vitality LLC is voluntarily recalling all 2020 Lots of CORE essential nutrients and Immune Boost Sublingual Vitamin D3. CORE has been found to contain an unapproved food additive, hordenine HCl, rendering it adulterated. Immune Boost Labeling was found to contain statements that [ Read more ]

  • Dole Fresh Vegetables Announces Limited Recall of Organic Romaine Hearts

    Dole Fresh Vegetables, Inc. is voluntarily recalling a limited number of cases of organic romaine hearts. The products being recalled are Dole™ Organic Romaine Hearts 3pk (UPC 0-71430-90061-1), combined English/French packaging, with Harvested-On dates of 10-23-20 and 10-26-20, and Wild Harvest Orga [ Read more ]

  • Fresenius Kabi Issues Voluntary Nationwide Recall of a Single Lot of Dexmedetomidine Hydrochloride Injection Due to Cross-Contamination of Lidocaine

    Fresenius Kabi USA is voluntarily recalling a single lot of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg /mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to a trace amount of lidocaine present in the lot. This recall is being performed to the [ Read more ]

  • Hong Thai Foods Corp Issues Allergy Alert on Undeclared Milk Allergens in Golden Boy Custard Muffin Original

    Hong Thai Foods Corp. of Brooklyn, NY is recalling its 7.76 ounce packages of Golden Boy Custard Muffin Original because they may contain undeclared milk allergens and are adulterated with Uranine- Acid Yellow 73. [ Read more ]

  • Fresh Express Recalls Limited Quantity of Expired Fresh Express Kit Caesar Supreme Due to Potential Health Risk

    Fresh Express is voluntarily recalling a limited number of cases of expired 10.5 oz. Fresh Express Kit Caesar Supreme with the Use-by Date of November 8, 2020 and Product Code S296 because it may be contaminated with Escherichia coli STEC 026 bacteria. The recall is being executed out of an abundanc [ Read more ]

  • Albright’s Raw Dog Food Recalls Chicken Recipe For Dogs Because of Possible Salmonella Health Risk

    Albright’s Raw Dog Food of Fort Wayne, IN is voluntarily recalling 67 cases of Chicken Recipe for Dogs because it has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especially if [ Read more ]

  • Kanan Enterprises Conducts Voluntary Recall of ALDI Southern Grove On the Go Sweet & Salty Trail Mix Due to Undeclared Almonds

    Out of an abundance of caution Kanan Enterprises announces the voluntary recall of ALDI Southern Grove On the Go Sweet & Salty Trail Mix 8 Pack Caddies 1.5 oz., Best By JUL 27 2021 due to the presence of almonds that are not listed as ingredients. People who have an allergy to almonds run the risk [ Read more ]

  • Lohxa LLC Issues Voluntary Nationwide Recall of Chlorhexidine Gluconate Oral Rinse USP, 0.12% Due to Microbial Contamination

    Lohxa, LLC is voluntarily recalling Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free (NDC:70166-027-15) products bearing an expiration date from 01/31/21 – 03/31/21 (see specific lots below) to the consumer level. This product is sourced and repackaged from Sunstar Americas Inc. who has no [ Read more ]

  • Tanimura & Antle Voluntary Recalls Packaged Single Head Romaine Lettuce Due to Potential E. Coli 0157:H7 Contamination

    Out of an abundance of caution, Tanimura & Antle Inc. is voluntarily recalling its packaged single head romaine lettuce under the Tanimura & Antle brand, labeled with a packed on date of 10/15/2020 or 10/16/2020, due to possible contamination with E. Coli 0157:H7. Packages contain a single head of r [ Read more ]
What's New: Drugs RSS Feed

  • GDUFA Paid Facilities List

    This list contains GDUFA facility payments received by the Agency. Data are extract from the User Fee System and GDUFA Facility User Fee Coversheets. The following table explains the terms used in the list: [ Read more ]

  • Patient Engagement Collaborative

    The Patient Engagement Collaborative (PEC) is an advancement in FDA’s efforts to strengthen its relationship with patient communities and is being coordinated by the FDA’s Patient Affairs Staff (PAS) in the Office of Clinical Policy and Programs (OCPP). [ 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 ]

  • Recently Issued Guidance Documents

    This page lists Recently Issued CBER and Cross-Center Guidance Documents. [ Read more ]

  • FDA Announces 4 Grant Awards for Projects Exploring the Use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making

    As part of the agency’s real-world evidence (RWE) efforts, the U.S. Food and Drug Administration is announcing four grant awards (RFA-FD-20-020) to examine the use of real-world data (RWD) to generate RWE in regulatory decision-making. [ Read more ]

  • Generic Drug Facilities, Sites and Organization Lists

    Generic Drug Facilities, Sites and Organization Lists [ Read more ]

  • UPDATED PUBLIC PARTICIPATION INFORMATION: July 14, 2020: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement - 07/14/2020 - 07/14/2020

    July 14, 2020: Meeting of the Oncologic Drugs Advisory Committee Meeting Announcement [ Read more ]

  • Why the United States-Mexico-Canada Agreement is Important to FDA

    How the many provisions in the United States-Mexico-Canada Agreement affect FDA, advance public health and FDA’s regulatory approaches. [ Read more ]

  • Human Drug Imports

    Human drug import information including PLAIR, safe importation action plan, and personal importation policy. [ Read more ]

  • Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program Submission Process

    The 21st Century Cures Act formally established a multi-step process for Drug Development Tools (DDT) qualification. Qualification of a DDT is for a specific context of use (COU), and the qualified DDT may be used for the COU by any person in drug or biologics development. [ Read more ]

  • Newly Added Guidance Documents

    Guidance documents represent the FDA's current thinking on a particular subject. New guidance documents are listed here for three months. [ Read more ]

  • Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry

    Clinical Pharmacology Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Guidance for Industry [ Read more ]

  • Drug Development Tool (DDT) Qualification Programs

    Information about the mission and objectives of FDA’s Drug Development Tool (DDT) qualification programs. [ Read more ]

  • Novel Drug Approvals for 2020

    The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public [ Read more ]

  • Drug Safety Oversight Board Meetings - Public Summaries

    This page provides summaries of past DSB Meetings. Each summary include DSCs posted since the last meeting, topics presented and discussed with the Board. Views expressed by non-CDER employees are those of the individual and not necessarily the opinion of his/her respective federal agency or Inst. [ Read more ]
Whats New Vaccines Blood Biologics RSS Feed

  • Coronavirus (COVID-19) Update: FDA Announces Advisory Committee Meeting to Discuss Second COVID-19 Vaccine Candidate

    FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 17, 2020 to discuss Moderna’s emergency use authorization request for a COVID-19 vaccine. [ Read more ]

  • COVID-19 Vaccines

    FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines. [ Read more ]

  • Patient Engagement Collaborative

    The Patient Engagement Collaborative (PEC) is an advancement in FDA’s efforts to strengthen its relationship with patient communities and is being coordinated by the FDA’s Patient Affairs Staff (PAS) in the Office of Clinical Policy and Programs (OCPP). [ Read more ]

  • Administrative Guidances

    This page lists Administrative Guidance documents. [ Read more ]

  • Recently Issued Guidance Documents

    This page lists Recently Issued CBER and Cross-Center Guidance Documents. [ Read more ]

  • What’s New for Biologics

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

  • Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Announcement - 12/10/2020 - 12/10/2020

    This is the CBER Vaccines and Related Biological Products Advisory Committee December 10, 2020 Meeting Announcement. [ Read more ]

  • Why the United States-Mexico-Canada Agreement is Important to FDA

    How the many provisions in the United States-Mexico-Canada Agreement affect FDA, advance public health and FDA’s regulatory approaches. [ Read more ]

  • Investigational COVID-19 Convalescent Plasma

    FDA is issuing this guidance to provide recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency. [ Read more ]

  • Roster of the Allergenic Products Advisory Committee

    As part of the Food and Drug Administration's (FDA's) ongoing efforts to recruit qualified experts with minimal conflicts of interest who are interested in serving on FDA advisory committees, FDA is requesting nominations for members to serve on its advisory committees. [ Read more ]

  • Field Science - Laboratory Manual

    The Laboratory Manual is a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used as an agency policy for testing consumer products, training of laboratory staff, report writing, safety, research, review of private laboratory reports and cour [ Read more ]

  • Learn About FDA Patient Engagement

    Learn about the different ways that patients and caregivers are working with the FDA to have their voice included in medical product approvals and FDA policy. [ Read more ]

  • 2020 Meeting Materials, Vaccines and Related Biological Products Advisory Committee

    This is the main page for the CBER 2020 Meeting Materials, Vaccines and Related Biological Products Advisory Committee. [ Read more ]

  • Devices Guidances

    This page lists Medical Device Guidance documents. [ Read more ]

  • Developing a Toolkit to Assess Efficacy of Ebola Vaccines and Therapeutics

    MCMi regulatory science project to research issues that are key to understanding and predicting if—and how—vaccines and therapeutics to prevent and treat Ebola will show efficacy [ Read more ]

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