The FDA WEBSITE provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products.

Not all recalls have press releases or are posted. See Additional information about recalls for a more complete listing.

Millions of masks used with sleep apnea machines are currently being recalled due to safety concerns.

Device Description
The recalled masks are worn by a patient when using a BiPAP or CPAP machine and have magnetic headgear clips to hold them in place. The recalled masks are for single patient use in the home or multi-patient use in the hospital or other clinical environments. The recalled masks are for patients weighing more than 66lbs (30kg), except for the Wisp Youth Nasal Mask and Therapy Mask 3100 NC/SP which are for patients seven years of age and older weighing more than 40lbs (18kg).

Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: FDA Safety Communication

The masks are for CPAP and BiPAP machines from Philips Respironics.

Figure 1: Amara View Full Face Mask
Figure 2: DreamWisp Nasal Mask
Figure 3: DreamWear Full Face Mask
Figure 4: Wisp and Wisp Youth Nasal Mask
Figure 5: Therapy Mask 3100 NC/SP

According to the Food & Drug Administration, the magnets in the mask can affect the function of the implanted metallic devices, such as brain stents, aneurysm clips and pacemakers.

Contraindication: Use of the mask is contraindicated for patients and their household members, caregivers and bed partners that may be in close vicinity to patients using the masks, that have implanted devices that may be affected by magnets, including but not limited to:

Pacemakers
Implantable cardioverter defibrillators (ICD)
Neurostimulators
Magnetic metallic implants/electrodes/valves placed in upper limbs, torso, or higher (i.e., neck and head)
Cerebral spinal fluid (CSF) shunts (e.g., ventriculo peritoneal (VP) shunt)
Aneurysm clips
Embolic coils
Intracranial aneurysm intravascular flow disruption devices
Metallic cranial plates, screws, burr hole covers, and bone substitute devices
Metallic splinters in the eye
Ocular implants (e.g., glaucoma implants, retinal implants)
Certain contact lenses with metal
Implants to restore hearing or balance that have an implanted magnet (such as cochlear implants, implanted bone conduction hearing devices, and auditory brainstem implants)
Magnetic denture attachments
Metallic gastrointestinal clips
Metallic stents (e.g., aneurysm, coronary, tracheobronchial, biliary)
Implantable ports and pumps (e.g., insulin pumps)
Hypoglossal nerve stimulators
Devices labeled as MR (Magnetic Resonance) unsafe
Magnetic metallic implants not labeled for MR or not evaluated for safety in a magnetic field

KING COUNTY, Wash. — Between 15,000 to 20,000 gallons of raw sewage leaked into Lake Washington Wednesday morning, closing a beach.

The county said bacteria from untreated sewage in the water is dangerous, especially to people with immune conditions.

Germs from the sewage in the water can cause problems such as rashes, diarrhea, stomachaches, fever and more.

Officials said it is also possible to get an infection in the eyes, ears, nose, throat or skin.

The beach that closed was Chism Beach Park, which is where a sign was put up warning people not to swim or go in the water.

People were also warned not to swim at Burrows Landing, located at 9505 Southeast 15th Street, or the Lake Washington shoreline between the.

A few hours after the leak, the King County Council was told some of the power equipment, which is supposed to keep raw sewage from flowing into water, is from the 1950s and 60s and is prone to failure.

“There are so many graduations in our community. This alerts is on safety since Covid is high and no one mentions it anymore. We have very fragile clients that are currently attending many graduation parties In order to make their families happy”. statement by concern community members.

“…. He gives us reason that we might Know good from bad wrong from right. This is the first to light our path, To gain His grace and shun his wrath. But gift of reason varies far, Some wise and others foolish are.” Moulana Mohammed Abdul-Aleem Siddiqui

According to the Consumer Product Safety Commission, the following consumer products were recalled in May 2022:

BIBS Baby Bottles from BIBS Denmark ApS

Heckler 9 Electric Bicycles from Santa Cruz Bicycles

GreenSpeed Magnum Recumbent Trikes from WizWheelz

Infant Clothes from Winter Water Factory

Children’s Robes from NewCosplay

Children’s Robes from Linum Home Textiles

Wolverine RMAX Off-Road Side-By-Side Vehicles from Yamaha

Hover-1 Superfly Hoverboards from DGL Group

Coffee Cups from Moderne Glass Company

Children’s Pajamas from Free Birdees

Wonder & Wise Activity Tables from Asweets

Children’s Sleepwear from Copper Pearl

If you believe you purchased a recalled product, stop using it and check its recall notice (linked above for all products). Follow the notice’s instructions, including where to return the product, how to get the product fixed, how to dispose of the product, how to receive a refund for the product, or what steps must be taken to receive a replacement product.

To view recalls issued prior to May, visit the Consumer Protection Safety Commission website.

Excerpt …. Accupril is used to treat hypertension which means to lower blood pressure. It can also be used to manage heart failure as adjunctive therapy when added to conventional therapy including diuretics or digitalis.

Although long-term ingestion of Nnitroso-quinapril may be associated with potential increased cancer risk in humans, there is no immediate risk to patients taking the medication. Patients currently taking the products are encouraged to consult with their doctor or health care provider about alternative treatment options for them.

The recalled product lots were distributed nationwide to wholesalers and distributors in the United States and Puerto Rico from December 2019 to April 2022. The full description of the recalled lots is listed below.

NDC Lot Number Expiration Date Strength Configuration/Count
0071-0530-23 DR9639 2023 MAR 31 10 mg 1 x 90 count bottle
0071-0532-23 DX8682 2023 MAR 31 20 mg 1 x 90 count bottle
0071-0532-23 DG1188 2022 MAY 31 20 mg 1 x 90 count bottle
0071-0535-23 DX6031 2023 MAR 31 40 mg 1 x 90 count bottle
0071-0535-23 CK6260 2022 MAY 31 40 mg 1 x 90 count bottle

The FDA has requested that wholesalers and distributors stop distribution and quarantine the product immediately. Those who received the affected products should contact Sedgwick at 888-345-0481 for instructions on how to return their product and how to receive reimbursement.

https://www.mytwintiers.com/news-cat/pitzer-recalls-tablets-due-to-increased-cancer-risk/amp/

Skippy Foods has recalled 60,000 jars (totaling 161,692 pounds) of its Reduced Fat Peanut Butter and its Creamy Peanut Butter Blend With Protein. The jars may contain fragments of stainless steel.

Skippy issued the recall “after a repair to a piece of equipment where a small piece of it may have fallen into a jar,” a company spokesperson told Consumer Reports. “We haven’t received any complaints and don’t expect consumers to have an issue.”

Skippy Reduced Fat Creamy Peanut Butter Spread (40-ounce jars) with the UPC code 37600-10520 and “best by” dates of May0423 and May0523 (located on the lid).

Skippy Reduced Fat Creamy Peanut Butter Spread Club Pack (two 40-ounce jars) with the UPC code 37600-10667 and a “best by” date of May0523 (located on the lids).

Skippy Reduced Fat Super Chunk Peanut Butter Spread (16.3-ounce jars) with the UPC code 37600-10499 and “best by” dates of May0623 and May0723 (located on the lid).

Skippy Creamy Peanut Butter Blended with Plant Protein (14-ounce jars) with the UPC code 37600-88095 and a “best by” date of May1023 (located on the lid).

The peanut butters were shipped to stores in California, Connecticut, Delaware, Florida, Hawaii, Illinois, Indiana, Kansas, Massachusetts, Minnesota, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Oklahoma, and Wisconsin.

“Foreign objects can be hard to spot in foods, and if you bit down on a piece of metal, you might injure your teeth or mouth,” says James E Rogers, PhD, director of food safety and testing at Consumer Reports.

If you have one of these products, return it to the store where you purchased it for a refund, or call Skippy Foods Consumer Engagement at 866-475-4779, 9 a.m. to 5 p.m. ET.

“Our QC [quality control] team has conducted a full investigation and will continue to go through all of the quality control steps that are in place to ensure food safety,” the Skippy spokesperson said.

Trisha Calvo

WASHINGTON (Reuters) -Ford Motor Co is recalling 737,000 vehicles in the United States over a part that could develop an oil leak and a software error that could hinder braking, it said on Friday.

The automaker is recalling 345,451 of its 2020-2022 Ford Escape and,

2021-2022 Ford Bronco Sport vehicles with 1.5L engines because the engine oil separator housing could crack and develop an oil leak that might cause an engine fire.

Ford said it had reports of at least eight fires that may be related to the issue but no related injuries or crashes.

Dealers will inspect the oil separator for damage or oil leaks, and replace the oil separator and seals, as necessary.

Ford is also recalling 391,836 2021-2022 F-150, 2022 Ford Maverick, Expedition, Lincoln avigator, F-250, F-350, F-450 and F-550 vehicles because a towed trailer equipped with an electric or electric-over hydraulic brake system might not brake.

Dealers will update the integrated trailer brake control module software.

Ford has 67 reports of improper function potentially related to the issue but no reports of crashes or injuries related to the recall.

Pfizer Voluntary Nationwide Recall of Lots of ACCURETIC™ (quinapril HCl/hydrochlorothiazide), quinapril and hydrochlorothiazide Tablets, and quinapril HCl/hydrochlorothiazide Tablets Due to N-Nitroso- Quinapril Content

Pfizer Inc. is recalling a blood pressure drug because of elevated levels of a potential cancer-causing impurity.

The product lots were distributed nationwide to wholesalers and Distributors in the United States and Puerto Rico from November 2019 to March 2022.

The company warned consumers on Monday of several tainted lots of Accuretic and two other versions of the drug — quinapril and hydrochlorothiazide tablets – because of the presence of a nitrosamine above the Acceptable Daily Intake level.

“Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines,” according to the Food and Drug Administration.

It adds: “These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.”

The medications are prescribed for the treatment of hypertension to reduce the risk of cardiovascular events, primarily strokes and myocardial infarctions

Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 10/12.5 mg
Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 20/12.5 mg
Accuretic™ (quinapril HCl/hydrochlorothiazide) tablets, 20/25 mg
NDC Lot Number Expiration Date Strength Configuration/Count
0071-3112-23 FG5379 08/2024 10/12.5 mg 1 x 90 count bottle
0071-0222-23 EA6686 04/2022 10/12.5 mg 1 x 90 count bottle
0071-5212-23 FG5381 08/2024 20/12.5 mg 1 x 90 count bottle
0071-0220-23 EA6665 04/2022 20/12.5 mg 1 x 90 count bottle
0071-0220-23 CN0640 04/2022 20/12.5 mg 1 x 90 count bottle
0071-0223-23 ET6974 02/2023 20/25 mg 1 x 90 count bottle

quinapril and hydrochlorothiazide tablets, 20/25 mg
quinapril HCl/hydrochlorothiazide tablets, 20/12.5 mg
quinapril HCl/hydrochlorothiazide tablets, 20/25 mg
NDC Lot Number Expiration Date Strength Configuration/Count
59762-5225-9 FE3714 02/2023 20/25 mg 1 x 90 count bottle
59762-0220-1 DN6931 03/2023 20/12.5 mg 1 x 90 count bottle
59762-0220-1 ED3904 03/2023 20/12.5 mg 1 x 90 count bottle
59762-0220-1 ED3905 03/2023 20/12.5 mg 1 x 90 count bottle
59762-0223-1 DP3414 02/2023 20/25 mg 1 x 90 count bottle

REMEMBER THE CORONAVIRUS IS AIRBORN (Sisters In Common,03/22/2022)

SHANGHAI (Reuters) – Not a single country managed to meet the World Health Organization’s (WHO) air quality standard in 2021, a survey of pollution data in 6,475 cities showed on Tuesday, and smog even rebounded in some regions after a COVID-related dip.

The WHO recommends that average annual readings of small and hazardous airborne particles known as PM2.5 should be no more than 5 micrograms per cubic metre after changing its guidelines last year, saying that even low concentrations caused significant health risks.

But only 3.4% of the surveyed cities met the standard in 2021, according to data complied by IQAir, a Swiss pollution technology company that monitors air quality. As many as 93 cities saw PM2.5 levels at 10 times the recommended level.

“There are a lot of countries that are making big strides in reduction,” said Christi Schroeder, air quality science manager with IQAir. “China started with some very big numbers and they are continuing to decrease over time. But there are also places in the world where it is getting significantly worse.”

India’s overall pollution levels worsened in 2021 and New Delhi remained the world’s most polluted capital, the data showed. Bangladesh was the most polluted country, also unchanged from the previous year, while Chad ranked second after the African country’s data was included for the first time.

China, which has been waging war on pollution since 2014, fell to 22nd in the PM2.5 rankings in 2021, down from 14th place a year earlier, with average readings improving slightly over the year to 32.6 micrograms, IQAir said.

Hotan in the northwestern region of Xinjiang was China’s worst performing city, with average PM2.5 readings of more than 100 micrograms, largely caused by sandstorms.

It fell to third on the list of the world’s most polluted cities after being overtaken by Bhiwadi and Ghaziabad, both in India.

(Reporting by David Stanway; Editing by Christian Schmollinger)

Kao USA Inc. out of Cincinnati is asking customers to check their bottles of Jergens Ultra Healing Moisturizer. Those with 3 oz. and 10 oz. sizes could qualify as part of the recall.

The company said that bottles manufactured between Oct. 1, 2021 and Oct. 18, 2021 have the potential to contain a bacterium known as Pluralibacter gergoviae, which can pose a risk for infection in those with weakened immune systems.

“We are working with our partners on improved cleaning and sanitization practices so that similar issues can be prevented in the future,” the company said in a statement.

The products are also being pulled from shelves and warehouses, the company said.

“We are working with our partners on improved cleaning and sanitization practices so that similar issues can be prevented in the future,” the company said in a statement.

The products are also being pulled from shelves and warehouses, the company said.

Those who have questions or who are interested in a refund can call 1-800-742-8798. Find out more about the recall right here.

Summary

Company Announcement Date:
October 14, 2021
FDA Publish Date:
October 14, 2021
Product Type:
Drugs

Reason for Announcement:
API batches above the specification limit for the impurity, a probable human carcinogen, (a substance that could cause cancer).

Company Name:
Lupin Pharmaceuticals, Inc.

Brand Name:
Lupin

Product Description:
Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5 mg and 300mg/12.5 mg, which is a probable human carcinogen (a substance that could cause cancer).

Risk Statement: N-nitrosoirbesartan impurity is a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests.

From October 8, 2018 (the earliest date of shipment from the manufacturing site of any of the affected batches), to September 30, 2021, Lupin received 4 reports of illness from Irbesartan and 0 reports from Irbesartan and Hydrochlorothiazide.

Irbesartan tablet USP is an angiotensin II receptor blocker indicated for treatment of hypertension, to lower blood pressure, diabetic nephropathy in hypertensive patients with type 2 diabetes, an elevated serum creatinine, and proteinuria. Irbesartan Tablets USP 75mg, 150mg and 300mg is packaged in 30 and 90 count bottles and was distributed nationwide in the US to wholesalers, drug chains, mail order pharmacies and supermarkets. Lupin discontinued the marketing of Irbesartan Tablets on Jan 7, 2021.

WASHINGTON, Aug. 24, 2021 – Willow Tree Poultry Farm, an Attleboro, Mass. establishment, is recalling approximately 52,022 pounds of various chicken salads and dip products that may be contaminated with extraneous materials, specifically hard white plastic the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The ready-to-eat (RTE) various chicken salads and dip items were produced on August 10, 2021 through August 13, 2021. The following products are subject to recall:

5-lb container of “Willow Tree Premium White Meat Caesar Chicken Dip” with sell by dates of 09/03/2021 and 09/06/2021.
5-lb and 12-oz containers of “Willow Tree Premium White Meat Buffalo Chicken Dip” with sell by dates of 09/03/2021 and 09/05/2021.
5-lb container of “Willow Tree Premium White Meat Buffalo Chicken Salad” with a sell by date of 09/07/2021.
15-oz container of “Willow Tree Premium White Meat Buffalo Chicken Salad” with sell by dates of 09/07/2021 and 09/09/2021.
15-oz container of “Willow Tree Premium White Meat Cranberry Walnut Chicken Salad” with a sell by date of 09/08/2021.
15-oz container of “Willow Tree Premium White Meat Classic Chicken Salad” with sell by dates of 09/07/2021, 09/08/2021, 09/09/2021, 09/10/2021.
7.5-oz container of “Willow Tree Premium White Meat Classic Chicken Salad” with sell by dates of 09/07/2021 and 09/09/2021.
10-lb container of “Willow Tree Premium White Meat Classic Chicken Salad” with a sell by date of 09/08/2021.

The products subject to recall bear establishment number “EST. P-8827” inside the USDA mark of inspection. These items have been shipped to wholesale and retail locations in Connecticut, Massachusetts, Maine, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, and Vermont.

The problem was discovered after the company received a consumer complaint and notified FSIS.

Deli meats linked to multi-state salmonella sicknesses
By Sandee LaMotte, CNN

Updated: Thu, 26 Aug 2021 01:03:22 GMT

Source: CNN

“Until we identify which Italian-style meats are making people sick, heat all Italian-style meats to an internal temperature of 165°F or until steaming hot before eating if you are at higher risk,” the CDC advised.

A dozen people have been hospitalized with salmonella and two dozen sickened as of August 24 in multistate outbreaks of two different strains of salmonella, the US Centers for Disease Control and Prevention announced Wednesday.

People who became sick reported eating salami, prosciutto and other deli meats that can be found in antipasto or charcuterie assortments before their illness.

The states involved in the Typhimurium outbreak are: Arizona, California, Nevada, Washington, Utah, Colorado, Minnesota, Wisconsin, Michigan, Illinois, Ohio, Virginia, Maryland and Indiana.

“Investigators are working to identify specific contaminated products and determine if the two outbreaks are linked to the same food source,” the CDC said.

“Until we identify which Italian-style meats are making people sick, heat all Italian-style meats to an internal temperature of 165°F or until steaming hot before eating if you are at higher risk,” the CDC advised.

You are at higher risk from a severe salmonella sickness if you are 65 years or older, have a chronic health or immune-compromising condition, or take any medications that lower your immunity and your body’s ability to fight germs.

“Children younger than 5 years are also more likely to get very sick from Salmonella,” the CDC said.

The case count of infections of both outbreaks is likely much larger, the CDC said, as it can take weeks for reports of illness to be alerted, counted and investigated. In addition, the CDC said, many people could have mild illnesses that are not reported.

A strain of salmonella called Typhimurium infected a group of 23 people from 14 states between the end of May and July 27, the CDC said. Laboratory testing found that 20 of these cases were resistant to common antibiotics such as chloramphenicol, streptomycin, sulfamethoxazole and tetracycline.

Nine people have been hospitalized, but no deaths have been reported.

A different strain

Another 13 people were infected between early May and the end of June with a strain called Salmonella Infantis, which typically strikes children under 2. Those sickened ranged in age from 1 to 74 years; of those, three have reportedly been hospitalized.

No deaths have been reported, and laboratory testing found no antibiotic resistance.

The states involved in the Infantis strain outbreak include Washington, Oregon, California, Arizona, Texas, Minnesota and New York.

Symptoms of salmonella

Symptoms of salmonella usually begin within 12 to 72 hours of consuming contaminated food. These can include diarrhea, abdominal cramps and fever that lasts between four and seven days, the CDC said.

Most people recover on their own, but those who experience persistent diarrhea may need to be hospitalized. In rare cases, the infection can enter the bloodstream and cause severe illness

GM has announced that it is recalling every Chevrolet Bolt made to date, including new electric utility vehicle models, over concerns that a manufacturing defect in the cars’ LG-made batteries could cause a fire.

We are continuing to take action to protect everyone at risk from this cyberattack, including those additional persons we recently identified. We have sent communications to millions of customers and other affected individuals and are providing support in various ways.

This includes:
 Offering two years of free identity protection services with McAfee’s ID Theft Protection Service to any person who believes they may be affected
 Recommending that all eligible T-Mobile customers sign up for free scam-blocking protection through Scam Shield
 Supporting customers with additional best practices and practical security steps like resetting PINs and passwords
 Publishing a customer support webpage that includes information and access to these tools at https://www.t-mobile.com/brand/data-breach-2021

What you can do ??? CLICK ABOVE ON “VISIT WED SITE”

“Single-use plastic bags are not easily recyclable, which makes managing them at the end of their lives almost impossible,” said Laurie Davies, manager of Ecology’s Solid Waste Management Program.

Additionally, recycling plastic bags is made difficult because they tend to be more of a contaminant in the recycling system by clogging sorting machines, which in turn puts workers at risk.

The bags, according to DEC, are a common form of pollution that threatens the health of wildlife, the environment and even humans.

When chemicals are released from the production, use, incineration and even slow decay of plastic bags, they pose a risk to organic life.

If customers choose to use compliant plastic or paper bags from a business, the ban requires that the business charge 8 cents per bag.

Plastic bags that are exempt from the law include plastics to wrap meat and produce, bags for prescriptions and bags for newspapers and dry-cleaning.

Other efforts in the state to reduce single-use plastics also include new legislation signed into law by Gov. Jay Inslee on May 17 that will increase recycled content in bottles and trash bags.

As the world continues to battle COVID-19 and communities strive to get back to business, it is more important than ever to raise confidence in the safety of buildings and shared spaces.

Lady Gaga, Jennifer Lopez, Michael B. Jordan, Robert DeNiro, Venus Williams, Wolfgang Puck, Deepak Chopra and 17th Surgeon General Richard Carmona came together in a new integrated ad campaign to raise awareness about the importance of the WELL Health-Safety Rating, an evidence-based third-party designation to verify that a building or space has taken the necessary steps to prioritize the health and safety of their staff, visitors and other stakeholders.

As such, the seal is a symbol of trust and confidence that is backed by science, structure and, most importantly, third-party verification. IWBI has seen thousands of buildings enroll in the program since its launch in July 2020.

“Look for the WELL Health-Safety Seal. The WELL Health-Safety Rating brings together building expertise and nearly a decade of health science to promote indoor safety, creating an efficient and cost-effective opportunity to guide, validate, recognize and scale efforts to manage critical health and safety issues in shared spaces. The WELL Health-Safety Rating examines 22 features across five core areas – Cleaning and Sanitization Procedures, Emergency Preparedness Programs, Health Service Resources, Air and Water Quality Management, and Stakeholder Engagement and Communication – and requires a minimum of 15 criteria be met in order to achieve the rating and be awarded the WELL Health-Safety seal.

The WELL Health-Safety Seal” Public Awareness Campaign featuring ambassadors, Lady Gaga, Jennifer Lopez, Michael B. Jordan, Robert DeNiro, Venus Williams, Wolfgang Puck, Deepak Chopra and 17th U.S. Surgeon General Richard Carmona, encourage people to look for buildings and spaces with the WELL Health-Safety seal on their windows or doors to feel more confident in their decision to go inside.

Directed by Spike Lee, the Star-studded Campaign Will Drive Awareness of Practices to Promote Healthier and Safer Indoor Spaces Through the WELL Health-Safety Rating.

RECALL – Sure Scents 2-1 Peaceful Stream/Moonlit Waves Candle

Consumer Contact:
Dollar Tree at 800-876-8697 from 9 a.m. to 5 p.m. ET Monday through Friday, or online at www.dollartree.com, then on the bottom of the page, under “Customer Service,” click “Contact Us,” then “Company Questions & Answers,” and click on “Product Recalls” in the left column for more information

Name of product:
Sure Scents 2-1 Peaceful Stream/Moonlit Waves Candles
Hazard:
The candles’ high flames can ignite the surface of the wax or cause the glass to break, posing fire and burn hazards.

Remedy:
Refund
Recall date:
December 2, 2020
Units:
About 142,740