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Saturday, apr 27
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US Food and Drug Administration
Business
Supplements Sold Nationwide Being Recalled Due To Presence Of 'Gas Station Heroin' In Products
Federal Health officials are cautioning consumers to avoid certain products that may contain an ingredient known as "gas station heroin." Neptune Resources LLC announced a voluntary recall of all lots of "Neptune's Fix Elixir," "Neptune's Fix Extra Strength Elixir," and Neptune's Fix Tablets due to the possible presence of tianeptine, the US Food and Drug Administration (FDA) announced. Tianeptine, which has been called "gas station heroin" by some, is not FDA-approved for any medical use, and its presence in the products prompted the nationwide recall. "The presence of tianepti…
Lifestyle
Contamination Concerns Prompt Nationwide Robitussin Cough Syrup Recall
Two types of Robitussin cough syrup products sold nationwide are being recalled due to potential microbial contamination, federal authorities announced. This week, New Jersey-based Haleon announced a recall of several lots of Robitussin Honey CF Max Day Adult and Robitussin Honey CF Max Nighttime Adult that could be contaminated, according to the US Food and Drug Administration (FDA). Recalled items include: Four- and eight-ounce Robitussin Honey CF Max Day Adult with these lot numbers/expiration dates: T18010 with an expiration date of Oct. 31, 2025; T08730 with an…
Business
Applesauce Pouches May Have Been Intentionally Contaminated: FDA
Lead contamination from applesauce that sickened dozens of youngsters may have been an "intentional act," a US Food and Drug Administration (FDA) official said in a brand-new report. The WanaBana Apple Cinnamon Fruit Purée Pouches were distributed nationwide through online and retail stores. The products subject to the recall, along with lot codes, are: WanaBana apple cinnamon fruit puree pouches – including three packs of 2.5 oz. - with the following lot codes shown on this page from the (FDA). Schnucks-brand cinnamon-flavored applesauce pouches and variety pack, 90g pouches, were …
Business
Massive Eye Drop Recall Expands: 3 Products Added As List Hits 29; Here's New Rundown
Three new products have been added to a recall of more than two dozen over-the-counter eye drops because of the risk of eye infections that may lead to vision loss or blindness. The now 29 products are from these brands: CVS Health, Leader (Cardinal Health), Rugby (Cardinal Health), Rite Aid, Target Up&Up, and Velocity Pharma. The alert comes after FDA investigators found bacterial contamination in critical drug production areas of a manufacturing facility. The list the US Food and Drug Administration (FDA) provided late last month five Cardinal Health, Inc. p…
News
Covid-
19: FDA Approves Updated Booster Shots Targeting New Variants
Health officials are one step closer to rolling out updated COVID-19 vaccines just in time for a rise in cases heading into the fall and winter months. The US Food and Drug Administration (FDA) approved new vaccines on Monday, Sept. 11, that are meant to better target currently circulating COVID-19 variants and provide better protection against hospitalization and death, the agency announced. Monday’s move affects vaccines manufactured by Moderna and Pfizer. The updated mRNA vaccines are each approved for people ages 12 and older and are authorized under emergency use for children ages 6 mo…
News
Restaurants, Stores Warned Not To Sell Contaminated Oysters From This Area In New England
Federal officials are warning restaurants and stores across the Northeast to stop selling oysters harvested from an area in Connecticut, as they may be contaminated with pathogens that cause food poisoning. The US Food and Drug Administration has advised consumers, restaurants, and retailers across several states in the Northeast to dispose of raw oysters harvested from the Groton Approved Area in New London County between Monday, Aug. 28 and Wednesday, Aug. 30, officials announced on Tuesday, Sept. 5. The affected raw oysters were sent to retailers and distributors in Connectic…
News
Covid-
19: Recall Issued For Brand Of Rapid Tests That Could Produce Inaccurate Results
A manufacturer has recalled more than 56,000 COVID-19 rapid tests because they could produce inaccurate results. Universal Meditech Inc. issued the recall for Skippack Medical Lab antigen tests because they were distributed without appropriate clearance or approval by the US Food and Drug Administration (FDA). The kits were made from October 2021 to December 2021 and distributed in January 2022. The following styles/models have been recalled: Name of Product: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit UDI: None Model: Cassette Products were distributed with “Sk…
Business
Covid-
19: Recall Issued For Brand Of Over-Counter Tests That Could Give False Negative Results
A new recall has been issued for a brand of COVID-19 tests due to an increased chance that the tests may give false negative results Detect, Inc. is voluntarily recalling specific lots of the Detect COVID-19 Test, an over-the-counter test used to identify SARS-CoV-2 (the virus that causes COVID-19) in self-collected nasal swabs. The recall affects 11,102 tests shipped to customers from July 26, 2022, through Aug. 26, 2022, the company said. The test was granted Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) in October, 2021. There is an increased chance t…
News
Common Drug Shortage Hits US
There's a shortage of some commonly found medications as this cold and flu season is off to the worst start in more than a decade, according to the US Food and Drug Administration (FDA). According to VOX, the reason for the shortages could be either due a lack of raw materials or a problem at the manufacturing plant. The following drugs and medications might be more difficult to find on shelves this year, according to the FDA: Albuterol Sulfate Inhalational Solution: Caused by a high-demand for the drug at the onset of the COVID-19 pandemic, VOX says. Amoxicillin (Oral Powder for Suspensi…
Business
Recall Issued Issued For Several Shampoo Products Due To Possible Cancer-Causing Agents
Several shampoo products are being recalled due to the presence of possible cancer-causing agents. The US Food and Drug Administration has announced the recall of select dry shampoo aerosol products produced prior to October 2021 by Dove, Nexxus, Suave, TIGI (Rockaholic and Bed Head), and TRESemmé due to "potentially elevated levels of benzene," FDA officials said. The recall was issued by Unilever on Tuesday, Oct. 18, the company that owns the brands of the recalled products. A complete list of recalled products is available here. Benzene is classified as a carcino…
News
Former Massachusetts EMT Pleads Guilty To Messing With Fentanyl Vials: DOJ
A former Massachusetts EMT is facing up to 10 years in prison after pleading guilty to tampering with liquid fentanyl vials at her ambulance company, the US Attorney's Office for Massachusetts reports. Candice Mangan, of Medford, was a part-time EMT who tampered with three fentanyl citrate vials by replacing the fentanyl citrate with saline, the office reports. This happened while Mangan was working in Needham on or about September 20, 2020. Tampering with such vials could jeopardize patents' health, according to Fernando P. McMillan, special agent in charge of the U.S…
News
Covid-
19: New Booster Shots Targeting Omicron Variant Approved By FDA
It’s time to roll up your sleeve and get another COVID-19 vaccine. On Wednesday, Aug. 31, the US Food and Drug Administration (FDA) approved updated versions of COVID booster shots made by Pfizer and Moderna that target the highly contagious BA.5 Omicron subvariant. The updated vaccine boosters are designed to give people broad protection against COVID and can help protect against severe illness, hospitalization, and death, the FDA said in a statement. Pfizer’s modified booster was authorized for people ages 12 and older, while Moderna’s shot was approved for those 18 and up. People who…
News
Covid-
19: Vaccines For Kids Under 5 Unanimously Recommended By Expert FDA Panel
Federal health officials are moving closer to authorizing COVID-19 vaccines for the youngest Americans. The US Food and Drug Administration (FDA) voted on Wednesday, June 15 to recommend authorizing both the Moderna and Pfizer COVID-19 vaccines for children between the ages of 6 months and 5 years old. On Wednesday, the agency’s independent panel of experts voted to recommend the vaccines - which are currently only available for Americans 5 years and older - for younger children. All 21 members of the FDA's Vaccines and Related Biological Products Advisory Committee unanimously voted to a…
Business
National Recall Issued For Rainbox Sprinkles Products
A popular rainbow sprinkle product is being recalled, according to federal health officials. Illinois-based Wilton Industries initiated a voluntary recall of certain lots of Rainbow Chip Crunch Sprinkles And Rainbow Sprinkles Mix that may contain milk and could still be on store shelves, the US Food and Drug Administration (FDA) issued an alert on Monday, June 6. Rainbow Chip Crunch SprinklesFDA According to the FDA, the undeclared allergen is not declared on the product label after the issue was discovered earlier this month. Recalled items include: Rainbow Chip Crunch Sprinkles wi…
News
Covid-
19: FDA Expands Eligibility For Pfizer Booster To Children 5 Through 11
Federal health officials have granted emergency use authorization for a booster dose of the Pfizer-BioNTech COVID-19 vaccine in children. On Tuesday, May 17, the US Food and Drug Administration (FDA) announced that it is expanding eligibility for boosters to include children between the ages of 5 and 11 years old. That age group will be permitted to receive their booster shot five months after completing their initial COVID-19 vaccination series, officials said. FDA Commissioner Robert Califf said that while data shows COVID-19 is less severe in children, the vaccine and boosters can help …
Business
Covid-
19: New Recall Issued For Rapid Tests, FDA Says
A new recall has been issued for some COVID-19 rapid tests that are not authorized for distribution, the US Food and Drug Administration announced on Tuesday, May 10. The FDA is warning people not to use the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold). Click here for the product codes. "This test is not authorized, cleared, or approved by the FDA for distribution or use in the United States," said the FDA, noting it "is concerned about the risk of false results when using this test because SML Distribution LLC has not provided the FDA with adequate data to show the t…
News
Covid-
19: Moderna Seeks Approval For Second Booster Shot For All Adults
Though the COVID-19 case numbers across the country have either plateaued or are showing improvement, Moderna is now seeking federal approval to administer a second booster shot for adults. Moderna is seeking an amendment of the US Food and Drug Administration’s emergency use authorization for its COVID-19 vaccine to allow for a fourth vaccine to adults 18 and older who have gotten an initial booster. The move by Moderna comes days after Pfizer and BioNTech submitted a similar request for authorization of an additional booster shot, though that vaccine would only be eligible for adults 65 a…
News
Covid-
19: FDA Announces New At-Home Test Recall
Federal health officials are cautioning Americans not to use a specific COVID-19 at-home testing kit that has not been approved or authorized by medical authorities. The US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), are advising against the use of the LuSys Laboratories COVID-19 Antigen Test because they have not been cleared for use. In total, nearly 165,000 at-home kits are subject to the recall, according to the FDA. Officials said that the LuSys Laboratories COVID-19 Antigen Test uses a nasal swab, or a saliva (spit) sample intended to de…
News
Covid-
19: Don't Use This Specific At-Home Test, FDA Warns
Federal health officials are cautioning Americans not to use a specific at-home rapid COVID-19 test that is being distributed but has yet to be authorized. The US Food and Drug Administration (FDA) issued an alert to advise that people should not use the ACON Laboratories test “Flowflex SARS-CoV-2 Antigen Rapid Test (Self Testing” that is packaged in a dark blue box (see above). Officials said that the test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States, and the agency is concerned about the risk of false results from those using it. T…
News
Covid-
19: Here's When FDA May Roll Out Fourth Vaccine Dose
Federal health officials have started discussing when to potentially roll out another COVID-19 booster shot as the world continues combating the pandemic. US Food and Drug Administration (FDA) officials said this week that they have been assessing the latest COVID-19 data, though it is too early to commit to a potential fourth dose of the vaccine for Americans. FDA spokesperson Alison Hunt told CNN that they are “indeed continually looking at the emerging data on the pandemic and variants in the United States and overseas in order to evaluate the potential utility and composition of booster…
News
Infant Formula Recalled Nationwide For Possible Health Risks
Infant formula sold across the US is being recalled after testing found that the product "did not meet specific nutrition and labeling requirements for infant formula, even though it is marketed as such.” The US Food and Drug Administration (FDA) announced that Moor Herbs is recalling all 16-ounce bottles of Angel Formula sold since February 2019 due to the presence of too much iron, sodium, and potassium, and too little Vitamin D. Officials said that the former issue could cause an overload of iron or an electrolyte imbalance, while the lack of Vitamin D could cause rickets, “a softening …
News
Covid-
19: Pfizer Expected To Seek Approval For Boosters For All Adults
Pfizer and European partner BioNTech are expected to seek federal authorization to administer its COVID-19 booster shot to all Americans over the age of 18. As soon as this week, the biopharmaceutical company is reportedly planning to seek US Food and Drug Administration (FDA) approval for booster shots for anyone 18 and older. Currently, only Americans 65 and older, those who are immunocompromised and anyone whose job puts them at a larger risk for exposure are eligible for Pfizer booster shots. The FDA is considered likely to grant the request, potentially before Thanksgiving and the hol…
News
Covid-
19: FDA Advisory Panel Votes To Recommend Moderna Booster For Certain Groups Of People
A US Food and Drug Administration (FDA) advisory panel has endorsed emergency authorization for Moderna’s half-dose COVID-19 vaccine booster shot for certain groups of people. The latest guidance from the feds calls for Moderna booster shots to be administered at least six months following the completion of the two-dose vaccination process for certain groups. Currently, the booster is recommended for people 65 and older and Americans between the ages of 18 and 64 who are immunocompromised and at a greater occupational risk of exposure or severe side effects from the virus. Related story …
News
Covid-
19: Pfizer Asks FDA To Approve Vaccine For Children Ages 5 To 11
Pfizer has officially asked the US Food and Drug Administration (FDA) for emergency use authorization for its COVID-19 vaccine to be administered to children between the ages of 5 and 11. With parents and politicians alike agreeing that keeping children learning in the classroom after a lost year in 2020, Pfizer is pushing to allow its vaccine to be administered among younger Americans. Pfizer tweeted this week that the company had submitted their formal request for Emergency Use Authorization of the vaccine to the FDA. "With new cases in children in the U.S. continuing to be at a high lev…
News
Covid-
19: Don't Use Certain Hand Sanitizers That May Contain Cancer-Causing Chemicals, FDA Says
The US Food and Drug Administration (FDA) is cautioning some Americans against using a certain hand sanitizer that could potentially contain high levels of potentially cancer-causing chemicals. An alert was issued by the FDA this week advising that it found unacceptable levels of benzene, acetaldehyde, and acetal contaminants in certain artnaturals brand scent-free hand sanitizer labeled with “DIST. by artnaturals Gardena, CA 90248.” According to the FDA, consumers should not use any artnaturals hand sanitizer products, saying the company has not replied to the FDA to help identif…
News
Covid-
19: Johnson & Johnson To Seek Authorization For Booster Shot
Johnson & Johnson is seeking federal approval for its COVID-19 booster shots, which could make it the latest to be authorized by the US Food and Drug Administration (FDA). On Monday, Oct. 4, a spokesperson for the pharmaceutical company announced that they were looking to gain approval to begin administering booster shots for its one-dose vaccine. Last month, regulators authorized a booster shot for some recipients of the Pfizer vaccine and are considering authorization this month for recipients of the Moderna vaccine. In total, according to reports, more than 15 million Am…
News
Covid-
19: Drugmaker To Seek Emergency Approval For Pill To Treat Virus
A new pharmaceutical company is throwing its hat in the ring as the country continues its fight against COVID-19. Merck and Ridgeback Biotherapeutics announced on Friday, Oct. 1 that it is planning to apply for federal emergency approval of a pill that can reportedly help prevent hospitalizations and deaths in COVID-19 patients. According to the company, trials have found that the pill - dubbed molnupiravir - could potentially reduce the risk of hospitalization or death in patients with mild to moderate COVID-19 by approximately 50 percent. The results of the late-stage trial have bee…
Schools
Covid-
19: School District In Western Mass Considering Vaccine Mandate
A school district in Western Massachusetts is considering a COVID-19 vaccination mandate to go along with orders to wear facial coverings while in school buildings. Officials in the Amherst-Pelham Regional School District are considering taking the extra step to provide extra protection against the spread of the virus by mandating faculty and staff members all get the COVID-19 vaccine. The decision will now move forward to a special school committee vote. Officials noted that if mandated, particular religious and health exemptions would have to be agreed upon between the school and its se…
News
Covid-
19: FDA Likely To Approve Brand-New Time Frame For Booster Shot
The timeline for COVID-19 booster shots may be accelerated as the US Food and Drug Administration (FDA) is expected to approve booster shots for all Americans after six months, not eight, as previously announced. According to reports, as more data is examined by federal health officials, it is more likely that booster shots will be required sooner than later for the Pfizer and Moderna vaccines. Before they can go into arms, the FDA must authorize booster shots for each vaccine. A spokesperson for the agency said that under its general policy it "cannot comment on or confirm the existence" o…
News
Covid-
19: FDA Grants Full Approval For Pfizer Vaccines, With More Mandates Now Expected
The US Food and Drug Administration (FDA) has granted full approval to the Pfizer/BioNTech COVID-19 vaccine for anyone 16 and older. On Monday, Aug. 23, the FDA announced that the Pfizer vaccine has been granted full approval, which is expected to potentially open the door for more COVID-19 vaccine mandates. The Pentagon will mandate vaccines for its 1.4 million active-duty service members, following the FDA approval Monday. United Airlines recently said its employees will be required to show proof of vaccination within five weeks of regulatory approval. Pfizer is the first COVID-1…
Schools
Covid-
19: Increase In Cases Among Children Could Be 'Just The Beginning,' Experts Say
With new COVID-19 infections and hospitalizations threatening to overwhelm hospitals in some parts of the country, officials are cautioning that the rise in cases among children “is just the beginning.” As the new academic year approaches, top US health experts are cautioning that the rise in new COVID-19 cases among children who are still ineligible to get vaccinated is likely to get worse when classes resume. According to the American Academy of Pediatrics (AAP), more than 121,000 new COVID-19 cases were reported in the US among children last week, more than 14 times the weekly number as…
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