US FDA News: Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland: FDA Safety Communication

The FDA is alerting patients who had mammograms at Capitol Radiology, LLC in Laurel, Maryland, on or after June 26, 2018, about possible problems with the quality of their mammograms.
Read more: Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland: FDA Safety Communication

US FDA News: Loud Muscle Science, LLC Issues Voluntary Recall of Launch Sequence Capsules Due to the Presence of Undeclared Tadalafil in United States and Canada

Hauppauge, NY, Loud Muscle Science, LLC is voluntarily recalling the following Launch Sequence products and lots listed in the table below to the consumer level. Laboratory analysis undertaken at the request of Loud Muscle Science, LLC found the products to be tainted with tadalafil, an ingredient i
Read more: Loud Muscle Science, LLC Issues Voluntary Recall of Launch Sequence Capsules Due to the Presence of Undeclared Tadalafil in United States and Canada

US FDA News: Copiktra (duvelisib): Drug Safety Communication - FDA Warns about Possible Increased Risk of Death and Serious Side Effects

FDA is warning that results from a clinical trial show a possible increased risk of death with Copiktra (duvelisib) compared to another medicine to treat a chronic blood cancer.

Read more: Copiktra (duvelisib): Drug Safety Communication - FDA Warns about Possible Increased Risk of Death and Serious Side Effects

US FDA News: FDA Infant Formula Update: June 30, 2022

FDA Infant Formula Update June 30 Danone New Zealand
Read more: FDA Infant Formula Update: June 30, 2022

US FDA News: Update: Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland: FDA Safety Communication

The FDA is alerting patients who had mammograms at Capitol Radiology, LLC on or after June 26, 2018, about possible problems with the quality of mammograms.
Read more: Update: Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland: FDA Safety Communication

US FDA News: Coronavirus (COVID-19) Update: FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses

The FDA has advised manufacturers seeking to update their COVID-19 vaccines that they should develop modified vaccines that add an omicron BA.4/5 spike protein component to the current vaccine composition to create a two component (bivalent) booster vaccine, beginning in Fall 2022.
Read more: Coronavirus (COVID-19) Update: FDA Recommends Inclusion of Omicron BA.4/5 Component for COVID-19 Vaccine Booster Doses

US FDA News: Bryant Ranch Prepack Inc. Issues Voluntary Nationwide Recall of Morphine Sulfate 30 mg Extended Release and Morphine Sulfate 60 mg Extended-Release Due to Label-Mix Up

Burbank, California, Bryant Ranch Prepack Inc. is voluntarily recalling one lot of Morphine Sulfate 30 mg Extended-Release tablets (Comprised of 10 bottles), and one lot of Morphine Sulfate 60 mg Extended-Release tablets (Comprised of 10 bottles) to the consumer level listed in the table below. The
Read more: Bryant Ranch Prepack Inc. Issues Voluntary Nationwide Recall of Morphine Sulfate 30 mg Extended Release and Morphine Sulfate 60 mg Extended-Release Due to Label-Mix Up

US FDA News: FDA Roundup: June 28, 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: June 28, 2022

US FDA News: FDA Infant Formula Update: June 28, 2022

FDA Infant Formula Update June 28 Abbott (Ireland)
Read more: FDA Infant Formula Update: June 28, 2022

US FDA News: Do Not Use Baby Neck Floats Due to the Risk of Death or Injury: FDA Safety Communication

The FDA is warning health care providers, parents and caregivers that there is a risk of death or injury in babies who use neck floats.
Read more: Do Not Use Baby Neck Floats Due to the Risk of Death or Injury: FDA Safety Communication

US FDA News: GE Healthcare Recalls CARESCAPE R860 Ventilator Due to Early Failure of Backup Batteries that May Cause Unexpected Ventilator Shut Down

If a CARESCAPE R860 ventilator is running on backup batteries and the battery fails, the ventilator may suddenly shut down and stop supporting the patient.
Read more: GE Healthcare Recalls CARESCAPE R860 Ventilator Due to Early Failure of Backup Batteries that May Cause Unexpected Ventilator Shut Down

US FDA News: FDA Introduces Innovative Proposal to Advance Consumer Access to Nonprescription Drugs

Today, the FDA issued a proposal to broaden the range of marketed nonprescription drugs available to consumers.
Read more: FDA Introduces Innovative Proposal to Advance Consumer Access to Nonprescription Drugs

US FDA News: FDA Infant Formula Update: June 27, 2022

FDA Infant Formula Update June 27 Bellamy (Australia)
Read more: FDA Infant Formula Update: June 27, 2022

US FDA News: FDA Roundup: June 24, 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: June 24, 2022

US FDA News: Medtronic Recalls HeartWare HVAD System Batteries Due to Battery Failure

The welding defect may cause the battery to malfunction and no longer provide power or prevent the battery from holding a full charge or properly recharging.
Read more: Medtronic Recalls HeartWare HVAD System Batteries Due to Battery Failure

US FDA News: Baxter Healthcare Corporation Recalls Volara System For Risk Of Respiratory Distress In Ventilated Patients During Home Use

When the Volara system’s in-line ventilator adaptor is used at home with a ventilator, it may prevent the patient from getting enough oxygen.
Read more: Baxter Healthcare Corporation Recalls Volara System For Risk Of Respiratory Distress In Ventilated Patients During Home Use

US FDA News: BD Announces Voluntary Recall on Intraosseous Products

BD (Becton, Dickinson and Company), a leading global medical technology company, announced a voluntary recall on the BDTM Intraosseous Needle Set Kits, BDTM Intraosseous Manual Driver Kits and BDTM Intraosseous Powered Drivers.
Read more: BD Announces Voluntary Recall on Intraosseous Products

US FDA News: Vi-Jon, LLC Issues Voluntary Nationwide Recall of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination

Vi-Jon, LLC is voluntarily recalling 1 (one) lot of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) to the consumer level. Testing identified the affected lot of the product to contain the bacteria Gluconacetobacter liquefaciens.
Read more: Vi-Jon, LLC Issues Voluntary Nationwide Recall of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination

US FDA News: FDA Infant Formula Update: June 22, 2022

FDA exercises enforcement discretion to Global Kosher to import various Kendamil infant formula products from United Kingdom following review of nutritional adequacy and safety information, including microbiological testing, labeling, facility production and inspection history
Read more: FDA Infant Formula Update: June 22, 2022

US FDA News: FDA Provides Update on Efforts to Increase Supply and Availability of Safe and Nutritious Infant Formula

FDA is providing an update on steps it has taken and will take to ensure safe and nutritious infant formula
Read more: FDA Provides Update on Efforts to Increase Supply and Availability of Safe and Nutritious Infant Formula

US FDA News: FDA Announces Plans for Proposed Rule to Reduce Addictiveness of Cigarettes and Other Combusted Tobacco Products

The Biden-Harris Administration published plans for future potential regulatory actions that include the FDA’s plans to develop a proposed product standard that would establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products.
Read more: FDA Announces Plans for Proposed Rule to Reduce Addictiveness of Cigarettes and Other Combusted Tobacco Products

US FDA News: Pulse Oximeter Accuracy and Limitations: FDA Safety Communication

The FDA is informing patients and health care providers that pulse oximeters have limitations and a risk of inaccuracy that must be considered.
Read more: Pulse Oximeter Accuracy and Limitations: FDA Safety Communication

US FDA News: FDA Alerts Providers and Patients to Check for Premature Battery Depletion in Certain Medtronic Pacemakers: FDA Safety Communication (UNPUBLISHED)

The FDA is issuing this safety communication to alert health care providers and patients about issues that may cause batteries in certain Medtronic implantable pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) to drain more quickly than expected.
Read more: FDA Alerts Providers and Patients to Check for Premature Battery Depletion in Certain Medtronic Pacemakers: FDA Safety Communication (UNPUBLISHED)

US FDA News: Draeger, Inc Recalls SafeStar 55 Breathing System Filters for Possible Obstructions That May Block Oxygen Flow To Patients

SafeStar 55 Breathing System Filters reduce contaminants to ventilated patients. A defective lot may have obstructions that keep patients from getting oxygen.
Read more: Draeger, Inc Recalls SafeStar 55 Breathing System Filters for Possible Obstructions That May Block Oxygen Flow To Patients

US FDA News: FDA Warns People with Diabetes and Health Care Providers Against the Use of Devices for Diabetes Management Not Authorized for Sale in the United States: FDA Safety Communication (UNPUBLISHED)

The FDA is warning of risks associated with the use of devices for diabetes management unauthorized for sale in the U.S., whether used alone or along with other devices.
Read more: FDA Warns People with Diabetes and Health Care Providers Against the Use of Devices for Diabetes Management Not Authorized for Sale in the United States: FDA Safety Communication (UNPUBLISHED)

US FDA News: UPDATE on Type III Endoleaks Associated with Endovascular Graft Systems – Letter to Health Care Providers

UPDATE on Type III Endoleaks Associated with Endovascular Graft Systems
Read more: UPDATE on Type III Endoleaks Associated with Endovascular Graft Systems – Letter to Health Care Providers

US FDA News: Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication

Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication
Read more: Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication

US FDA News: FDA Infant Formula Update: June 17, 2022

FDA exercises enforcement discretion to Danone to import Aptamil infant formula products from Ireland following review of nutritional adequacy and safety information, including microbiological testing, labeling, facility production and inspection history.
Read more: FDA Infant Formula Update: June 17, 2022

US FDA News: FDA Roundup: June 17, 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: June 17, 2022

US FDA News: Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age

The FDA authorized emergency use of the Moderna COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include use in children down to 6 months of age.
Read more: Coronavirus (COVID-19) Update: FDA Authorizes Moderna and Pfizer-BioNTech COVID-19 Vaccines for Children Down to 6 Months of Age

US FDA News: FDA Infant Formula Update: June 15, 2022

FDA exercises enforcement discretion to Mead Johnson Nutrition/Reckitt to import Enfamil Stage 1 infant formula products from Singapore following review of nutritional adequacy and safety information, including microbiological testing, labeling, facility production and inspection history.
Read more: FDA Infant Formula Update: June 15, 2022

US FDA News: Latin Foods Market Issues Voluntary Nationwide Recall of Artri King Reforzado Con Ortiga Y Omega 3 Due to the Presence of Undeclared Diclofenac and Dexamethasone

Latin Foods Market is voluntarily recalling one lot, LOTE 334 21, of Artri King Reforzado con Ortiga y Omega 3 tablets to the consumer level.
Read more: Latin Foods Market Issues Voluntary Nationwide Recall of Artri King Reforzado Con Ortiga Y Omega 3 Due to the Presence of Undeclared Diclofenac and Dexamethasone

US FDA News: FDA Roundup: June 14, 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: June 14, 2022

US FDA News: UPDATE: Potential Risk of Infection When Using Heater-Cooler Devices – Letter to Health Care Providers

The FDA provides updated information from our ongoing evaluation of NTM infections in patients who have had cardiothoracic surgery using heater-cooler devices.
Read more: UPDATE: Potential Risk of Infection When Using Heater-Cooler Devices – Letter to Health Care Providers

US FDA News: FDA Approves First Systemic Treatment for Alopecia Areata

The FDA approved a treatment for adults with severe alopecia areata, a disorder that often appears as patchy baldness and affects more than 300,000 people in the U.S. each year.
Read more: FDA Approves First Systemic Treatment for Alopecia Areata

US FDA News: FDA Roundup: June 10, 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: June 10, 2022

US FDA News: FDA Infant Formula Update: June 10, 2022

FDA exercises enforcement discretion to Abbott to import various Similac infant formula products from Spain following review of nutritional adequacy and safety information, including microbiological testing, labeling, facility production and inspection history.
Read more: FDA Infant Formula Update: June 10, 2022

US FDA News: Green Pharmaceuticals Inc Issues Voluntary Nationwide Recall of SnoreStop NasoSpray Due to Microbial Contamination

Camarillo, California, Green Pharmaceuticals Inc is voluntarily recalling lot 2373/21222 of SnoreStop NasoSpray, packaged in 0.3 FL OZ (9ml) bottles to the consumer level. FDA testing found product to contain microbial contamination identified as Providencia rettgeri. This microorganism is rarely as
Read more: Green Pharmaceuticals Inc Issues Voluntary Nationwide Recall of SnoreStop NasoSpray Due to Microbial Contamination

US FDA News: FDA Infant Formula Update: June 9, 2022

FDA exercises enforcement discretion to Nestlé to import NAN Expert Pro Sensi Pro infant formula from Germany following review of nutritional adequacy and safety information, including microbiological testing, labeling, facility production and inspection history.
Read more: FDA Infant Formula Update: June 9, 2022

US FDA News: Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum Hydroxide /Simethicone Oral Suspension Due to Microbial Contamination

Lawrence, Kansas – Plastikon Healthcare, LLC is voluntarily recalling one (1) lot of Milk of Magnesia 2400 mg/10 mL Oral Suspension, one (1) lot of Milk of Magnesia 2400 mg/30 mL Oral Suspension, eleven (11) lots of Magnesium Hydroxide 1200 mg/Aluminum Hydroxide 1200 mg/Simethicone 120 mg per 30 mL
Read more: Plastikon Healthcare Issues Voluntary Nationwide Recall of Milk of Magnesia Oral Suspension and Magnesium Hydroxide /Aluminum Hydroxide /Simethicone Oral Suspension Due to Microbial Contamination

US FDA News: FDA Launches Campaign Aimed at Preventing E-Cigarette Use Among American Indian/Alaska Native Youth

The FDA launches youth e-cigarette prevention campaign, "Next Legends," to educate American Indian/Alaska Native (AI/AN) youth about the harms of vaping.
Read more: FDA Launches Campaign Aimed at Preventing E-Cigarette Use Among American Indian/Alaska Native Youth

US FDA News: Medtronic Recalls HVAD Pump Implant Kit for Pump Weld Defect

Medtronic recalls pump implant kit due to a pump weld defect that may lead to corrosion of pump internal parts and cause the pump to rotate incorrectly.
Read more: Medtronic Recalls HVAD Pump Implant Kit for Pump Weld Defect

US FDA News: FDA Roundup: June 7, 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: June 7, 2022

US FDA News: Buzzagogo, Inc. Issues Voluntary Nationwide Recall of Allergy Bee Gone for Kids Nasal Swab Remedy Due to Potential Microbial Contamination

Nottingham, NH, Buzzagogo Inc. is voluntarily recalling one lot of Allergy Bee Gone for Kids Nasal Swab Remedy to the consumer level due to potential microbial contamination. FDA testing found some product to contain elevated levels of yeast & mold and may contain the bacteria Bacillus cereus.
Read more: Buzzagogo, Inc. Issues Voluntary Nationwide Recall of Allergy Bee Gone for Kids Nasal Swab Remedy Due to Potential Microbial Contamination

US FDA News: FDA Roundup: June 3, 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: June 3, 2022

US FDA News: Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or without Alarms

All Philips Respironics V60 and V60 Plus Ventilators are recalled due to a power issue that may cause ventilator to stop with or without an alarm.


Read more: Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or without Alarms

US FDA News: FDA Infant Formula Update: June 3, 2022

FDA exercises enforcement discretion to Nestlé to import Gerber Good Start Gentle infant formula from Mexico following review of nutritional adequacy and safety information, including microbiological testing, labeling, facility production and inspection history.
Read more: FDA Infant Formula Update: June 3, 2022

US FDA News: FDA Launches New Dietary Supplement Education Initiative for Consumers, Educators, and Healthcare Professionals

Today, FDA launched its “Supplement Your Knowledge” initiative, with materials for consumers, educators, and healthcare professionals to help educate, inform, and broaden their understanding of dietary supplements.
Read more: FDA Launches New Dietary Supplement Education Initiative for Consumers, Educators, and Healthcare Professionals

US FDA News: Atrium Medical Corporation Recalls iCast Covered Stent for Potential Balloon or Catheter Hub Separation That May Cause Patient Harm

The iCast catheter-placed stent supports the walls of structure within the body. The balloon or catheter hub may separate during removal, causing harm to the patient.
Read more: Atrium Medical Corporation Recalls iCast Covered Stent for Potential Balloon or Catheter Hub Separation That May Cause Patient Harm

US FDA News: FDA Infant Formula Update: June 2, 2022

FDA Infant Formula Update: June 2, 2022
Read more: FDA Infant Formula Update: June 2, 2022

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: Ukoniq (umbralisib): Drug Safety Communication - FDA Approval of Lymphoma Medicine is Withdrawn Due to Safety Concerns

Due to safety concerns, the FDA has withdrawn its approval for the cancer medicine Ukoniq (umbralisib). Updated findings from the UNITY-CLL clinical trial continued to show a possible increased risk of death in patients receiving Ukoniq.
Read more: Ukoniq (umbralisib): Drug Safety Communication - FDA Approval of Lymphoma Medicine is Withdrawn Due to Safety Concerns

US FDA News: Walmart Inc. Issues Voluntary Nationwide Recall of Various Artri Ajo King Joint Supplements Due to Potential Hidden Drug Ingredients

Walmart Inc. is voluntarily recalling all lots of Artri Ajo King Joint Supplements sold by Innovacion Naturals and PDX Supply Warehouse LLC on Walmart.com and shipped by Walmart to the consumer level. FDA laboratory analysis confirmed that Artri Ajo King Omega 3 Joint Support Supplement with LOTE LT
Read more: Walmart Inc. Issues Voluntary Nationwide Recall of Various Artri Ajo King Joint Supplements Due to Potential Hidden Drug Ingredients