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Tuesday, jun 18
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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
NY Companies Sold Adulterated, Misbranded Dietary Supplements, Feds Say
Federal regulators stepped in when a New York business owner allegedly sold dietary supplements that weren’t all they were cracked up to be. Mohammed Islam agreed to settle a civil complaint from the US Food and Drug Administration (FDA) in Brooklyn federal court on Monday, Dec. 18. The complaint, filed in October 2023, alleged that Islam’s Long Island-based companies – Total Body Nutrition, TBN Labs, and Loud Muscle Science – violated federal law by manufacturing and distributing adulterated and misbranded dietary supplements. Specifically, an investigation found that the companies failed…
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
Contaminated Oysters: NY Restaurants, Stores Warned To Not Sell Shellfish By FDA
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
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
NY Health Commissioner Orders All Pharmacies To Carry Overdose Medication Naloxone
Pharmacies in New York will soon be required to carry and dispense naloxone, the medicine used to quickly reverse the life-threatening effects of an opioid overdose. The state’s health commissioner, Dr. Mary Bassett, issued a statewide standing order for all pharmacies to carry the medication and dispense it without a prescription beginning Monday, Aug. 15. “This is as close as we can get to naloxone being 'over the counter' without action being taken by the US Food and Drug Administration,” Bassett said. Often sold under the brand name Narcan, naloxone is easily administered and can help…
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 …
Lifestyle
New York State To Provide Resources For Families Amid Baby Formula Shortage
Many New Yorkers got an unexpected alert on their cellphones as state officials seek to assist families struggling amid the nationwide baby formula shortage. On Friday, May 13, anyone who downloaded the NY State Excelsior Pass during the COVID-19 pandemic to prove their vaccination status received an alert advising that the state is prepared to provide resources to families. Original story - Parents, Retailers Deal With National Baby Formula Shortage According to New York Gov. Kathy Hochul, since the recall of certain powdered infant formula products in February, the US Food and Drug A…
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…
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