Tag: U.S. Food and Drug Administration (FDA)

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Jif Peanut Butter Under Recall For Potential Salmonella Contamination

Jif Peanut Butter Under Recall For Potential Salmonella Contamination

LEXINGTON, Kentucky — The U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are investigating an outbreak of salmonella infections that is possibly linked to Jif peanut butter products.

The J.M. Smucker Company issued a voluntary recall for its creamy, crunchy, natural and reduced fat peanut butter products that were distributed nationwide, with lot code numbers 1274425 to 2140425, the FDA announced this weekend.

Currently, 14 people have reported illnesses and two of those cases have resulted in hospitalizations, according to data provided by the CDC.

“Five out of five people reported consuming peanut butter and four of the five people specifically reported consuming different varieties of Jif brand peanut butter prior to becoming ill,” the FDA said.

What is salmonella?

Salmonella itself is a bacteria, but the illness it causes is known as salmonellosis.

For many infected people, symptoms appear 12 to 72 hours after contact and often include diarrhea, fever and abdominal cramps, according to the FDA. Most people who are infected recover within four to seven days and do not need any treatment.

More serious and severe cases can occur, though, so the FDA recommends contacting your health care provider if you believe you have been infected.

Several varieties of peanut butter are being recalled nationwide

The J. M. Smucker Co. said the peanut butter it is recalling was distributed in retail stores and other outlets throughout the country. It includes creamy, crunchy and natural varieties, along with many others.

The recalled products have lot code numbers between 1274425 – 2140425 and include the numbers 425 for the 5th-7th digits. “425” in that position indicates that it was processed in the Lexington facility.

This information is usually printed on the back label of the jar. A list of recalled products and their numbers can be seen on the FDA’s website.

If you happen to have a jar included in the recall, you should throw it away immediately.

The FDA noted that the peanut butter has a two-year shelf life so consumers should check any Jif peanut butter already in their home.

After throwing the peanut butter out, the CDC recommends washing and sanitizing any surfaces or containers that might have come into contact with the peanut butter.

No word as yet from the local Department of Licensing and Consumer Affairs (DLCA) as to whether the affected products were shipped to the U.S. Virgin Islands.

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FDA Investigates Lucky Charms Cereal After Reports of Sickness

FDA Investigates Lucky Charms Cereal After Reports of Sickness

SILVER SPRING, Maryland — The U.S. Food and Drug Administration is investigating Lucky Charms after consumers complained about becoming sick after eating the dry cereal.

The FDA said it received more than 100 complaints this year.

“The FDA takes seriously any reports of possible adulteration of a food that may also cause illnesses or injury,” the agency said in a statement, according to The Associated Press.

Lucky Charms, which is made by the Minneapolis-based General Mills, said it found no link between the cereal and illness.

FDA Investigates Lucky Charms Cereal After Reports of Sickness

“Food safety is our top priority. We take your concerns very seriously. Through our continuing internal investigations, we have not found any evidence of consumer illness linked to the consumption of Lucky Charms. Please send us a DM so that we can gather additional details,” Lucky Charms tweeted on Monday.

The website iwaspoisoned.com said it received more than 3,000 reports of people becoming sick after eating the cereal. People posting on the website said they experienced nausea, diarrhea, vomiting, and stomach pain.

“Starting in late 2021 Lucky Charms food poisoning reports started to trend on iwaspoisoned.com. Now there are reports of over 3,000 sick and the FDA has initiated an investigation. We recommend anyone who fell ill after eating Lucky Charms, to report it, and to keep left over product for testing. We will communicate procedures for testing to everyone who reports their case,” the website said.

General Mills said Lucky Charms was introduced in 1964. The cereal has multicolored oat pieces shaped like bells, fish, clovers, moon marshmallows and other objects. The cereal’s logo and mascot is a Leprechaun and one of his most popular catchphrases is that Lucky Charms are “magically delicious.”

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Jergens Ultra Healing Moisturizer Lotion Recalled Due To Possibly Harmful Bacteria

Jergens Ultra Healing Moisturizer Lotion Recalled Due To Possibly Harmful Bacteria

CHRISTIANSTED — The Virgin Islands Department of Health warned that Kao USA Inc., the makers of Jergens® Ultra Healing Moisturizer 3 oz and 10 oz products have issued a voluntary recall of these products.

According to Health, the precautionary recall was prompted by the possible presence of Pluralibacter gergoviae, a bacterium which typically poses little medical risk to healthy people. However, individuals with health problems such as weakened immune systems could be more susceptible to infections. Consumers are urged to discontinue use of the recalled Jergens® Ultra Healing Moisturizer 3 oz and 10 oz lotion as specified below.

Jergens Ultra Healing Moisturizer Lotion Recalled Due To Possibly Harmful Bacteria

VIDOH said an investigation is ongoing to determine the scope of the issue and the manufacture, Kao USA Inc., is taking voluntary, precautionary measures to proactively notifying consumers as well as to ensure sure all affected product is removed from warehouses and retail store shelves.

The 3 oz. and 10 oz. sizes of Jergens® Ultra Healing Moisturizer are the only lots affected by the recall. These products can be identified by date and UPC codes as follows:

  • Dates: Jergens® Ultra Healing Moisturizer manufactured between October 1, 2021 and October 18, 2021, could be impacted.
  • The affected lot codes for the 3 oz size (UPC 019100109971 for single bottles and 019100267114 for pack of 3) can be found on the back of the bottle printed in black ink and begin with the prefix “ZU”: ZU712851, ZU712911, ZU712861, ZU722851, ZU712871, ZU722881, ZU712881.
  • The affected lot codes for the 10 oz size (UPC 019100109988) can be found on the bottom of the bottle printed in black ink and begin with the prefix “ZU”: ZU722741, ZU732791, ZU722771, ZU732801, ZU722781, ZU732811, ZU732781, ZU732821. 

People who have one of the products from the recalled lots who would like to receive a free product coupon should contact the Kao USA Inc. Consumer Care Center at 1-(800) 742-8798 or send an email to: consumer@kao.com. The company’s hours of operation are Monday through Friday, 9:00 a.m. to 5:00 p.m., U.S. ET. Consumers will receive a postage paid label and plastic bag via mail to return the recalled product.

Consumers who experienced adverse events because of using these products should report their experience to the FDA’s Med Watch Program by:

  • Phone: 888-463-6332
  • Mail: MedWatch, The FDA Safety Information and Adverse Event Reporting Program, US Food and Drug Administration, Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, MD 20857-0001.
  • Website: MedWatch http://www.fda.gov/medwatch/ Complete and submit your report online at Reporting Serious Problems to FDA | FDA
  • Complete the report and send it via regular mail or Fax MedWatch Forms for FDA Safety Reporting | FDA or call 1-800-332-1088 to request a form. The completed form should be returned to the address on the pre-addressed form or faxed back to the FDA at 1-800-FDA-0178.

https://boston.cbslocal.com/video/6214966-jergens-ultra-healing-moisturizer-lotion-recalled-due-to-possibly-harmful-bacteria/

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FDA Warns Parents To Stop Using These Baby Formulas After 4 Infants Hospitalized

FDA Warns Parents To Stop Using These Baby Formulas After 4 Infants Hospitalized

STURGIS — Abbott Laboratories said on Thursday it was recalling powdered baby formulas, including Similac, made at a Michigan facility after four consumers complained about bacterial infections in infants who consumed the products.

The complaints were related to Cronobacter sakazakii bacteria or Salmonella. Newport and Abbott will also recall its Alimentum and EleCare baby formulas manufactured at the plant in Sturgis.

The U.S. Food and Drug Administration said in a statement that it was investigating consumer complaints of the infections.

“All four cases related to these complaints were hospitalized and Cronobacter may have contributed to a death in one case,” the health agency said.

Cronobacter sakazakii bacteria can cause serious invasive infections and premature infant death. The most recent U.S. outbreak spanned four states in 2011.

The FDA also said that a review of Abbott’s internal records indicated environmental contamination with Cronobacter sakazakii.

You can check if your powdered formula is affected by inspecting the code printed near the expiration date. Affected products have a code beginning with first two digits of 22 through 37 and containing K8, SH or Z2 and have an expiration date of April 1, 2022, or later.

Liquid baby formula and all other products produced by Abbott Nutrition are not affected.

Abbott Nutrition said it is cooperating with the FDA investigation into the three Cronobacter sakazakii infections and one salmonella infection, all of which required hospitalization. The one fatal case has not been confirmed to be solely related to a Cronobacter infection, according to the FDA.

The FDA said environmental samples from the facility have yielded positive results for the Cronobacter bacteria, but there have been no reports of salmonella so far. A review of Abbott’s records show that the company has destroyed products in the past due to the presence of Cronobacter.

Cronobacter infections are rare but can be especially dangerous for newborn babies.

Symptoms of a Cronobacter infection include poor feeding, jaundice and grunting breaths, according to the FDA. Those infected with salmonella might experience fever, diarrhea and abdominal cramps.

“We value the trust parents place in us for high quality and safe nutrition,” Abbott said in a statement provided to NPR. “We’ll do whatever it takes to keep that trust and resolve this situation.”

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Court Won’t Order Hospital To Use Deworming Drug On Michigan Man

Court Won’t Order Hospital To Use Deworming Drug On Michigan Man

ANN ARBOR, Michigan — The Michigan Court of Appeals won’t order a hospital to use a deworming drug to treat a man who has health problems related to COVID-19.

The court said it won’t disrupt the judgment of doctors at St. Joseph Mercy Hospital in Ann Arbor.

“A court directive in this matter could open the door for a flood of similar suits from other patients with COVID-19, not to mention other conditions, suing to obtain care that is contrary to hospital policies,” the court said Friday.

The daughter of a 68-year-old man sued after doctors refused to use ivermectin. The man was admitted to the hospital on November 6 with COVID-19.

The man still has severe lung problems and other health woes, but the coronavirus infection has eased, the court noted.

Ivermectin is approved by the U.S. Food and Drug Administration to treat infections of roundworms, lice and other tiny parasites in humans — not COVID-19. It has been promoted by conservative commentators despite a lack of conclusive evidence that it helps people with the virus.

The Michigan lawsuit is one of two dozen or more filed around the United States.

USVI Warned Not To Take Animal De-Worming Pills As Cure For COVID-19
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VIDOH Waits 3 Weeks To Warn Public On High Blood Pressure Medication Recall

VIDOH Waits 3 Weeks To Warn Public On High Blood Pressure Medication Recall

CHARLOTTE AMALIE — The Virgin Islands Health Department said that Lupin Pharmaceuticals has voluntarily recalled batches of two blood pressure drugs last month because they may contain high levels of a substance that could cause cancer.

“The recall is due to the potential presence of a probable human carcinogen based on results from laboratory tests,” according to Health.

Health Department spokesperson Rebekah Kubla did not respond questions as to why the department waited more than three weeks to notify the public of the recalled drug.

According to the statement, Lupin has received no reports of illness that appear to relate to this issue, but is recalling all batches of Irbesartan Tablets USP 75mg, 150mg and 300mg and Irbesartan and Hydrochlorothiazide Tablets USP, 150mg/12.5mg and 300mg/12.5mg in the U.S. “out of an abundance of caution.

“Lupin advises patients who are prescribed the drugs to continue taking their medication and contact their pharmacist, physician or medical provider for advice ‘regarding an alternative treatment,’ ” the Health Department said in the prepared statement.

The company, in an Oct. 14, statement from its Baltimore headquarters said the earliest shipment date of the drug was Sept. 8 and urged patients to discontinue taking the medication and to report any adverse reactions to the Food and Drug Administration’s MedWatch Adverse Event Reporting program online, by regular mail or by fax.

• Complete and submit the report at https://www.fda.gov/safety/medwatch-fda-safetyinformation-and-adverse-event-reporting-program/reporting-serious-problems-fda

• For regular mail or fax visit https://www.fda.gov/safety/medical-product-safetyinformation/medwatch-forms-fda-safety-reporting or call 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-332-0178.

The company also said it notified consumers, wholesalers, distributors, and retailers, but those with questions regarding the recall should contact Inmar Rx Solutions, Inc. at 855-769-3988 from 10 a.m, to 6 p.m., Monday through Friday.

For reimbursement, residents should have the recalled lots returned to Inmar Rx Solutions, Inc. The lot number can be found on the side of the bottle label.

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USVI Warned Not To Take Animal De-Worming Pills As Cure For COVID-19

USVI Warned Not To Take Animal De-Worming Pills As Cure For COVID-19

FREDERIKSTED — Local poison control experts today warned Virgin Islanders not to take dog de-worming pills as a cure for COVID-19.

National health officials on Monday warned against using a drug called ivermectin for unapproved use as a medicine to prevent or treat COVID-19.

“I was unable to find any calls/cases from USVI related to the use of ivermectin in our database, but we did discuss the rapid rise of cases on the mainland that we have experienced,” Dr. Jay Schauben told the Virgin Islands Free Press this morning.  “Second, ivermectin is an FDA approved drug with FDA approval for use as a “de-worming” agent.  It does not have FDA approval for use as a treatment for COVID-19.”

Ivermectin has been approved only as an anti-parasitic treatment for humans and animals such as livestock and horses, has been the subject of a spike in calls to the Mississippi Poison Control Center. 

USVI Warned Not To Take Animal De-Worming Pills As Cure For COVID-19

The drugs produced for humans are different than the drug made for livestock, which is “highly concentrated and is toxic to people, and can cause serious harm,” the Mississippi State Department of Health said in an alert Monday. At least two people have been hospitalized with potential ivermectin toxicity after ingesting the drug produced for livestock, the state’s poison control center said Monday.

Interest in the drug is rising as the delta variant of the coronavirus has spurred higher COVID-19 transmission rates and increased concern among the vaccinated about becoming infected.

Multiple reports of patients treated or hospitalized after “self-medicating with ivermectin intended for horses” led the Food and Drug Administration to issue a warning Friday. “You are not a horse. You are not a cow. Seriously, y’all. Stop it,” the agency tweeted.   

Monday, the FDA announced full approval of the Pfizer-BioNTech COVID-19 vaccine.

Ivermectin: What we know

Ivermectin in a pill form is used to treat parasitic worms in humans. A topical form of the drug is used to treat head lice and skin conditions such as rosacea, the FDA says.

Other forms of ivermectin are used to treat parasites in horses and cows and as a  heartworm medicine for dogs.

An ivermectin overdose can cause nausea, vomiting, diarrhea, low blood pressure, an allergic reaction such as itching or hives, seizures, dizziness, problems with balance, coma and potentially death, according to the FDA, which has warned consumers about the potential harm for months,

Dr. Schauben works for the Florida/USVI Poison Information Center based in Jacksonville, Florida,

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Dominican Republic Says Its Citizens Will Be Among The 1st In The World To Get The COVID-19 Vaccine; Will USVI People Be The Last?

Dominican Republic Says Its Citizens Will Be Among The 1st In The World To Get The COVID-19 Vaccine; Will USVI People Be The Last?

SANTO DOMINGO — Virgin Islands Department of Health Territorial Epidemiologist Dr. Esther Ellis said on November 17 that the territory would receive doses of the FDA-approved coronavirus vaccine “at the same time as the states.”

The question then becomes, how soon will that be? USA Today quoted FDA Commissioner Stephen Hahn today as saying that a COVID-19 vaccine could come be made available within weeks — at least, a limited supply to front-line medical workers. Drug companies Pfizer, Moderna and AstraZeneca have the leading coronavirus vaccine candidates. 

Public Health Minister, Plutarco Arias, on Monday said the vaccines that the Dominican Republic government has contracted with the pharmaceutical AstraZeneca, in conjunction with Oxford University, will begin to arrive in the country in February. Arias said doses of the COVID-19 vaccine will begin to be available to the public in March.

The Dominican Republic contracted 10 million doses for $40 million, already approved last week by the Chamber of Deputies in the D.R.

Interviewed by El Día, Arias said they have all the procedures ready and are only waiting on the delivery date.

“We have all the procedures with the three groups that are going to produce vaccines,” Arias said. “In that sense, that is already assured. The other most important part for us is the delivery time, as you already know there are many countries and they will deliver by part, by percentage. Possibly we will have vaccines available in February, but we will most certainly be administering it in March.”

Arias added that the country has already paid to be among the first in the world to receive the doses. He said the first people to be immunized are healthcare workers, people over 65 and those with pre-existing conditions.

BRYAN: Virgin Islanders Will Not Be Used As Guinea Pigs For Trump’s New Vaccine
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Romaine Lettuce Recall Hits Puerto Rico And 19 Other States

Romaine Lettuce Recall Hits Puerto Rico And 19 Other States

SALINAS — Tanimura and Antle Farms in California is voluntarily recalling thousands of heads of romaine lettuce over possible e. Coli contamination

The recall appeared on the Food and Drug Administration website.

The grower is recalling nearly 3,400 cartons distributed in 19 states and Puerto Rico under its namesake brand.

Each case has between a dozen and two dozen heads of lettuce.

Each head is individually packaged.

The labels say they were packed on October 15 or 16.

The recall is based on a random sample collected and analyzed by Michigan health officials.

There are no reports of sickness linked to the product.

Tanimura and Antle says the recall is being done out of an abundance of caution.

The lettuce was shipped to Alaska, Oregon, California, Texas, Arkansas, Oklahoma, Indiana, Nebraska, Missouri, Tennessee, Wisconsin, New Mexico, South Carolina, Washington, North Carolina, Ohio, Virginia, Massachusetts, Illinois and Puerto Rico.

SOURCE: CNN

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Tomorrow Is Prescription Drug Take-Back Day In The USVI And Puerto Rico

Tomorrow Is Prescription Drug Take-Back Day In The USVI And Puerto Rico

SAN JUAN — The DEA is holding its 19th National Prescription Drug Take Back Day tomorrow October 24 at locations across the U.S. Virgin Islands and Puerto Rico.

The nationwide event aims to provide a safe, convenient, and responsible means of disposing of prescription drugs, while also educating the public about the potential for abuse of medications.

Rates of prescription drug abuse in the United States are alarmingly high, as are the number of accidental poisonings and overdoses due to these drugs.

Tomorrow Is Prescription Drug Take-Back Day In The USVI And Puerto Rico

Collection sites will adhere to local COVID-19 guidelines and regulations in order to maintain the safety of all participants and local law enforcement.

“The initiative – now in its tenth year – addresses a vital public safety and public health issue,” DEA Acting Administrator Timothy Shea said. “Medicines that languish in home cabinets are highly susceptible to diversion, misuse, and abuse. Together with our partners, we are not only
holding National Prescription Drug Take Back Day, but offering other ways to dispose of unwanted, unused, and expired prescription medications.”

This service is free and anonymous, no questions asked.

“Every Take Back event is significant, on October 2019 over 3,300 pounds were collected in Puerto Rico and the USVIs,” A.J. Collazo, DEA Caribbean Division Special Agent in Charge said. “Due to the pandemic, many physical or emotional illnesses have increased the chances of accumulating prescription drugs in our homes and workplaces. Do not become a dealer without knowing it. Dispose of all medicines this Saturday or contact the FDA and EPA to learn how to dispose of them appropriately
any day of the year.”

The DEA and its partners will collect tablets, capsules, patches, and other solid forms.

“We are so grateful that DEA continues to provide opportunities for Virgin Islanders to dispose of unused prescription drugs,” Gretchen C.F. Shappert, United States Attorney for the Virgin Islands, said. “Removing these drugs from our homes makes our communities safer.”

The DEA wants the public to learn other ways they can dispose of unwanted prescription drugs without having to leave their homes. Both the U.S. Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) have tips on how to safely dispose of drugs at home.

The DEA will also accept vape pens or other e-cigarette devices from individual consumers, only after the batteries are removed from the devices.

If the battery cannot be removed, individual consumers can check
with large electronic chain stores who may accept the vape pen or e-cigarette devices for proper disposal.

Liquids, including intravenous solutions, syringes and other sharps, and illegal drugs cannot be dropped off.

Prescription Drug Take Back Locations, for Saturday, October 24th:

On St. Croix: Kingshill and Gallows Bay Post Offices, 10:00 a.m. to 2:00 p.m.

On St. Thomas: Sugar Estate Post Office, 10:00 a.m. to 2:00 p.m.

For more information on DEA’s National Prescription Drug Take Back Day, and to find a collection site near you, visit www.deatakeback.com