US FDA News: Magellan Diagnostics Recalls LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests Due to Risk of Falsely Low Results

The LeadCare tests are used to detect blood lead level but has risk of falsely low results.
Read more: Magellan Diagnostics Recalls LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests Due to Risk of Falsely Low Results

US FDA News: Iodine-Containing Contrast Media: Drug Safety Communication - FDA Recommends Thyroid Monitoring in Babies and Young Children Who Receive Injections of Iodine-Containing Contrast Media for Medical Imaging

The FDA is recommending that newborns and children through 3 years old have follow-up thyroid monitoring within 3 weeks after receiving injections of contrast media containing iodine, also called “contrast dye,” for X-rays and other medical imaging procedures.
Read more: Iodine-Containing Contrast Media: Drug Safety Communication - FDA Recommends Thyroid Monitoring in Babies and Young Children Who Receive Injections of Iodine-Containing Contrast Media for Medical Imaging

US FDA News: Unilever Issues Voluntary Nationwide Recall of Suave 24-Hour Protection Aerosol Antiperspirant Powder and Suave 24-Hour Protection Aerosol Antiperspirant Fresh Due to Presence of Slightly Elevated Levels of Benzene

Unilever United States is voluntarily recalling two Suave 24-Hour Protection Aerosol Antiperspirants to the consumer level. An internal review showed slightly elevated levels of benzene in some product samples. While benzene is not an ingredient in any of the recalled products, the review showed tha
Read more: Unilever Issues Voluntary Nationwide Recall of Suave 24-Hour Protection Aerosol Antiperspirant Powder and Suave 24-Hour Protection Aerosol Antiperspirant Fresh Due to Presence of Slightly Elevated Levels of Benzene

US FDA News: FDA Roundup: March 29, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: March 29, 2022

US FDA News: Teva Issues Voluntary Nationwide Recall of One Lot of IDArubicin Hydrochloride Injection USP 5 mg/5 mL Due to the Presence of Particulate Matter

Teva Pharmaceuticals has initiated a voluntary nationwide recall of lot 31329657B of IDArubicin Hydrochloride Injection USP 5 mg/5 mL vial, to the user level in the United States. This voluntary recall is initiated based on an internal inspection that found particulate matter in one vial of the prod
Read more: Teva Issues Voluntary Nationwide Recall of One Lot of IDArubicin Hydrochloride Injection USP 5 mg/5 mL Due to the Presence of Particulate Matter

US FDA News: Coronavirus (COVID-19) Update: FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals

The FDA authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain immunocompromised individuals.
Read more: Coronavirus (COVID-19) Update: FDA Authorizes Second Booster Dose of Two COVID-19 Vaccines for Older and Immunocompromised Individuals

US FDA News: Federal judge enters consent decree against New Jersey raw animal food manufacturer

A raw animal food manufacturer has been ordered to stop selling products until they come into compliance under the Federal Food, Drug, and Cosmetic Act
Read more: Federal judge enters consent decree against New Jersey raw animal food manufacturer

US FDA News: FDA Seeks $8.4 Billion to Further Investments in Critical Public Health Modernization, Core Food and Medical Product Safety Programs

FDA is announcing it is requesting a total budget of $8.4 billion as part of the President’s fiscal year 2023 budget for investments in critical public health modernization, core food safety and medical product safety programs.
Read more: FDA Seeks $8.4 Billion to Further Investments in Critical Public Health Modernization, Core Food and Medical Product Safety Programs

US FDA News: FDA Roundup: March 25, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: March 25, 2022

US FDA News: Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension 2400 mg/30 mL, Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL, and Acetaminophen 650mg/ 20.3mL, Unit Dose Cups, Due to Microbial Contamination

Lawrence, KS, Plastikon Healthcare, LLC is voluntarily recalling three (3) lots of Milk of Magnesia 2400 mg/30 mL Oral Suspension, one (1) lot of Acetaminophen 650mg/ 20.3mL, and six (6) lots of Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL to the hospital, clinic
Read more: Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension 2400 mg/30 mL, Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL, and Acetaminophen 650mg/ 20.3mL, Unit Dose Cups, Due to Microbial Contamination

US FDA News: FDA Issues Decisions on Additional E-Cigarette Products

FDA took additional actions as part of the agency’s work to ensure any electronic nicotine delivery system (ENDS) products available for sale have demonstrated that marketing of the products is appropriate for the protection of the public health.
Read more: FDA Issues Decisions on Additional E-Cigarette Products

US FDA News: Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Labeled for Research Use Only

): Certain Point of Care Celltrion USA’s DiaTrust COVID-19 Ag Rapid Tests are being recalled because they were labeled for Research Use Only but distributed to customers for non-research, unauthorized uses are being recalled.
Read more: Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Labeled for Research Use Only

US FDA News: Pfizer Voluntary Nationwide Recall of Lots of ACCURETICTM (Quinapril HCl/Hydrochlorothiazide), Quinapril and Hydrochlorothiazide Tablets, and Quinapril HCl/Hydrochlorothiazide Tablets Due to N-NitrosoQuinapril Content

Pfizer is voluntarily recalling Accuretic (quinapril HCl/hydrochlorothiazide) tablets distributed by Pfizer as well as two authorized generics distributed by Greenstone (quinapril and hydrochlorothiazide and quinapril HCl/ hydrochlorothiazide) to the patient(consumer/user) level due to the presence
Read more: Pfizer Voluntary Nationwide Recall of Lots of ACCURETICTM (Quinapril HCl/Hydrochlorothiazide), Quinapril and Hydrochlorothiazide Tablets, and Quinapril HCl/Hydrochlorothiazide Tablets Due to N-NitrosoQuinapril Content

US FDA News: FDA Statement on Medical Device User Fee Amendments (MDUFA)

FDA and representatives from the medical device industry have reached an agreement on proposed recommendations for the fifth reauthorization of the medical device user fee program.
Read more: FDA Statement on Medical Device User Fee Amendments (MDUFA)

US FDA News: Celltrion USA Recalls Certain Point of Care Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive Test Results and Unauthorized Shelf Life

Certain lots of Celltrion USA’s DiaTrust COVID-19 Ag Rapid Tests are being recalled for a high number of false positives and a longer shelf life than authorized by the FDA
Read more: Celltrion USA Recalls Certain Point of Care Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive Test Results and Unauthorized Shelf Life

US FDA News: FDA Roundup: March 22, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: March 22, 2022

US FDA News: Adamis Pharmaceuticals Corporation Issues Nationwide Voluntary Recall of SYMJEPI® (Epinephrine) Injection for Potential Manufacturing Defect

Adamis Pharmaceuticals Corporation (Nasdaq: ADMP) is voluntarily recalling certain lots of SYMJEPI (epinephrine) Injection 0.15 mg (0.15 mg/0.3 mL) and 0.3 mg (0.3 mg/0.3 mL) Pre-Filled Single-Dose Syringes to the consumer level. The batches in the table below are being recalled due to the potential
Read more: Adamis Pharmaceuticals Corporation Issues Nationwide Voluntary Recall of SYMJEPI® (Epinephrine) Injection for Potential Manufacturing Defect

US FDA News: Sandoz, Inc. Issues Nationwide Recall of 13 Lots of Orphenadrine Citrate 100 mg Extended Release Tablets Due to Presence of a Nitrosamine Impurity

Sandoz Inc. (“Sandoz”) is initiating a voluntary recall of 13 lots (listed below) of oral Orphenadrine Citrate 100 mg Extended Release (ER) Tablets to the consumer level.
Read more: Sandoz, Inc. Issues Nationwide Recall of 13 Lots of Orphenadrine Citrate 100 mg Extended Release Tablets Due to Presence of a Nitrosamine Impurity

US FDA News: Prefilled Saline Flush Syringe Conservation Strategies - Letter to Health Care Personnel

The FDA recommends conservation strategies to minimize the use of these prefilled saline flush syringes and maintain the quality and safety of care for patients.
Read more: Prefilled Saline Flush Syringe Conservation Strategies - Letter to Health Care Personnel

US FDA News: Philips Respironics Recalls Certain V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm

Certain Philips Respironics V60 and V60 Plus ventilators recalled due to expired adhesive that may cause ventilator to stop delivering ventilation with or without an alarm.
Read more: Philips Respironics Recalls Certain V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm

US FDA News: Coronavirus (COVID-19) Update: FDA to Hold Advisory Committee Meeting on COVID-19 Vaccines to Discuss Future Boosters

On Wed., April 6, FDA will hold a virtual meeting of its Vaccines and Related Biological Products Advisory Committee to discuss considerations for future COVID-19 vaccine booster doses and the strain selection process to address current and emerging variants during the Fall season 2022.
Read more: Coronavirus (COVID-19) Update: FDA to Hold Advisory Committee Meeting on COVID-19 Vaccines to Discuss Future Boosters

US FDA News: FDA Roundup: March 18, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: March 18, 2022

US FDA News: Use and Store At-Home COVID-19 Tests Properly to Avoid Potential Harm: FDA Safety Communication

These tests can be dangerous if the parts of the test kit are swallowed or if the liquid solutions touch a person’s skin or eyes.
Read more: Use and Store At-Home COVID-19 Tests Properly to Avoid Potential Harm: FDA Safety Communication

US FDA News: FDA, Reagan-Udall Foundation to Hold Important Public Workshop to Discuss Naloxone Access

The U.S. Food and Drug Administration in collaboration with the Reagan-Udall Foundation for the FDA will hold a virtual public workshop to discuss critical questions around access to naloxone, a drug used to reverse opioid overdoses.
Read more: FDA, Reagan-Udall Foundation to Hold Important Public Workshop to Discuss Naloxone Access

US FDA News: Celltrion USA Recalls Certain Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive Test Results and Unauthorized Shelf Life

Certain lots of Celltrion USA’s DiaTrust COVID-19 Ag Rapid Tests are being recalled for a high number of false positives and a longer shelf life than authorized by the FDA
Read more: Celltrion USA Recalls Certain Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive Test Results and Unauthorized Shelf Life

US FDA News: SD Biosensor Recalls STANDARD Q COVID-19 Ag Home Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results

SD Biosensor's STANDARD Q COVID-19 Ag Home Tests are being recalled because they are not authorized, cleared, or approved by the FDA and may give false results.
Read more: SD Biosensor Recalls STANDARD Q COVID-19 Ag Home Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results

US FDA News: FDA Roundup: March 15, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: March 15, 2022

US FDA News: Celltrion USA Recalls Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive Test Results and Unauthorized Shelf Life

Celltrion USA’s DiaTrust COVID-19 Ag Rapid Tests are being recalled for a high number of false positives and a longer shelf life than authorized by the FDA
Read more: Celltrion USA Recalls Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive Test Results and Unauthorized Shelf Life

US FDA News: FDA Approves First Generic of Symbicort to Treat Asthma and COPD

The FDA approved the first generic of Symbicort for the treatment of asthma and for the maintenance treatment of patients with COPD.
Read more: FDA Approves First Generic of Symbicort to Treat Asthma and COPD

US FDA News: LuSys Laboratories, Inc Recalls COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests Because They Are Not Authorized, Cleared, or Approved by the FDA

LuSys Laboratories recalled these tests because they do not have an EUA, 510(k), or PMA and therefore cannot be legally marketed and distributed in the U.S.
Read more: LuSys Laboratories, Inc Recalls COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests Because They Are Not Authorized, Cleared, or Approved by the FDA

US FDA News: FDA Warns Against Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication

Renuvion/J-Plasma has not been cleared for Aesthetic Skin Procedures. FDA warns patients & health care providers of potential risks.
Read more: FDA Warns Against Use of Renuvion/J-Plasma Device for Certain Aesthetic Procedures: FDA Safety Communication

US FDA News: ACON Laboratories Issues a Recall of Non-EUA Authorized “Flowflex™ SARS-CoV-2 Antigen Rapid Test (Self-Testing)” Tests From the U.S. Market

ACON Laboratories, Inc. (“ACON Laboratories”), the legal manufacturer of the “Flowflex™ COVID-19 Antigen Home Test” (FDA Emergency Use Authorization EUA210494), has identified the U.S. distribution of unauthorized, adulterated and misbranded counterfeit product having the trade name “Flowflex SARS-C
Read more: ACON Laboratories Issues a Recall of Non-EUA Authorized “Flowflex™ SARS-CoV-2 Antigen Rapid Test (Self-Testing)” Tests From the U.S. Market

US FDA News: FDA Roundup: March 11, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: March 11, 2022

US FDA News: Baxter recalls SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) due to the risk of not alarming for repeated upstream occlusion events

There is a risk of the pumps not delivering medication at the programmed rate displayed on the screen, and in some cases may not alarm for upstream occlusions.
Read more: Baxter recalls SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) due to the risk of not alarming for repeated upstream occlusion events

US FDA News: FDA Orders Philips Respironics to Notify Patients Regarding the Recall of Certain Breathing Assistance Machines

The FDA issued a notification order to Philips Respironics requiring the company to notify patients and others of the company’s recall of certain Philips Respironics ventilators, continuous positive airway pressure and bilevel positive airway pressure machines.
Read more: FDA Orders Philips Respironics to Notify Patients Regarding the Recall of Certain Breathing Assistance Machines

US FDA News: Olympia Pharmacy Issues Voluntary Nationwide Recall of Seven Compounded Products Due to Being Out-of-Specification

Olympia Pharmacy is voluntarily recalling 11 specific lots of Trimix Formulas F-9, T-105, SB-4, Sermorelin, Sincalide, Hydroxocobalamin, and NAD, compounded injectables to the consumer level. These compounded products were found to be out-of-specification.
Read more: Olympia Pharmacy Issues Voluntary Nationwide Recall of Seven Compounded Products Due to Being Out-of-Specification

US FDA News: Medtronic Recalls TurboHawk Plus Directional Atherectomy System Due to Risk of Tip Damage During Use

This device is used during an atherectomy to treat patients who have calcified narrowings and blockages in the peripheral arteries.
Read more: Medtronic Recalls TurboHawk Plus Directional Atherectomy System Due to Risk of Tip Damage During Use

US FDA News: FDA Roundup: March 8, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: March 8, 2022

US FDA News: Tennessee Technical Coatings Corp Issues Nationwide Voluntary Recall of Hand Sanitizer Isopropyl Alcohol Antiseptic 75% Due to Presence of Methanol

Tennessee Technical Coatings Corp. is voluntarily recalling all lots of HAND SANITIZER Isopropyl Alcohol Antiseptic 75% to the consumer/user level. FDA analysis has found the product to contain methanol.
Read more: Tennessee Technical Coatings Corp Issues Nationwide Voluntary Recall of Hand Sanitizer Isopropyl Alcohol Antiseptic 75% Due to Presence of Methanol

US FDA News: Fresenius Kabi Issues Voluntary Recall of Sodium Acetate Injection, USP Due to the Presence of Particulate Matter

Fresenius Kabi USA is voluntarily recalling seven lots of Sodium Acetate Injection, USP, 400 mEq/100 mL (4 mEq/mL), 100 mL fill in a 100 mL vial to the user level due to the presence of particulate matter found in reserve and/or stability sample vials. Microscopic and elemental analyses determined t
Read more: Fresenius Kabi Issues Voluntary Recall of Sodium Acetate Injection, USP Due to the Presence of Particulate Matter

US FDA News: FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review

FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review; Agency’s First Enforcement Discretion Decision for an IGA in an Animal for Food Use
Read more: FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review

US FDA News: FDA Roundup: March 4, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: March 4, 2022

US FDA News: B. Braun Medical Inc. Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride for Injection USP 250ML in Excel Due to Fluid Leakage or Low Fill Volume

B. Braun Medical Inc. (B. Braun) is voluntarily recalling five (5) lots of 0.9% Sodium Chloride for Injection USP 250ML in Excel within the United States to the hospital/user level.
Read more: B. Braun Medical Inc. Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride for Injection USP 250ML in Excel Due to Fluid Leakage or Low Fill Volume

US FDA News: FDA Urges Companies to be ’Recall Ready’ to Protect Public Health as Part of Final Guidance for Voluntary Recalls

FDA issues guidance to help companies prepare to quickly and effectively remove violative products from the market and limit the public’s exposure to risk.
Read more: FDA Urges Companies to be ’Recall Ready’ to Protect Public Health as Part of Final Guidance for Voluntary Recalls

US FDA News: FDA Roundup: March 1, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Read more: FDA Roundup: March 1, 2022

US FDA News: Do Not Use Certain ACON Flowflex COVID-19 Tests: FDA Safety Communication

The tests in a dark blue box have not been authorized, cleared, or approved. The FDA is concerned about the risk of false results when using these tests.
Read more: Do Not Use Certain ACON Flowflex COVID-19 Tests: FDA Safety Communication

US FDA News: Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests: FDA Safety Communication

These tests have not been authorized, cleared, or approved. The FDA is concerned about the risk of false results when using these tests.
Read more: Do Not Use SD Biosensor STANDARD Q COVID-19 Ag Home Tests: FDA Safety Communication

US FDA News: Do Not Use Certain Celltrion DiaTrust COVID-19 Tests: FDA Safety Communication

The tests in a green and white box have not been authorized, cleared, or approved. The FDA is concerned about the risk of false results when using these tests.
Read more: Do Not Use Certain Celltrion DiaTrust COVID-19 Tests: FDA Safety Communication

US FDA News: FDA Clinical Trial Guidances Share Biden Administration’s Goals for Advancing Development of Cancer Treatments

FDA Clinical Trial Guidances Share Biden Administration’s Goals for Advancing Development of Cancer Treatments
Read more: FDA Clinical Trial Guidances Share Biden Administration’s Goals for Advancing Development of Cancer Treatments