FDA News

04 November

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VitalityVita Issues Voluntary Nationwide Recall of VitalityXtra and PeakMax Capsules Due to the Presence of Undeclared Sildenafil and Diclofenac

Posted by Asebey Law

Sacramento, CA, VitalityVita.com is voluntarily recalling lot 230811, Exp 8/11/25, of VitalityXtra Capsules and PeakMax Capsules packaged in 10-count blisters in a cardboard carton to the consumer level. VitalityXtra was found to be tainted with sildenafil, an ingredient in FDA approved products for Read More (external link)...

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02 November

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Savencia Cheese USA Announces Voluntary Recall of Select Soft Ripened Cheeses

Posted by Asebey Law

Savencia Cheese USA is recalling select soft ripened cheeses manufactured in our Lena manufacturing facility because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and Read More (external link)...

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01 November

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Spa Owner Arrested for Allegedly Performing Thousands of Illegal Counterfeit Injections on Clients for Over Three Years

Posted by Asebey Law

FDA-OCI, Boston, Stoughton, Randolph, South Easton, Skin Beaute Med Spa, Rebecca Fadanelli Read More (external link)...

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01 November

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IPV Therapy Device Recall: Percussionaire Removes Certain Phasitron 5 Breathing Circuits Due to Risk of Nickel Exposure

Posted by Asebey Law

IPV Phasitron 5 breathing circuits help provide therapy to promote ventilation. Certain devices may expose patients to high levels of nickel. Read More (external link)...

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01 November

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HH Fresh Trading Corp Recalls Taiwan Enoki 200gx25pk Because of Possible Health Risk

Posted by Asebey Law

Because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms suc Read More (external link)...

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31 October

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Elevation Foods Issues Recall Due to Undeclared Soy in Hannaford Seafood Salad

Posted by Asebey Law

Danvers, Massachusetts. R. Walters LLC dba Elevation Foods is recalling 1,668 units of mislabeled Hannaford Seafood Salad 12oz because it contains an undeclared Soy allergen. Consumers with an allergy or severe sensitivity to soy run the risk of serious or life-threatening allergic reaction if they Read More (external link)...

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31 October

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Tainted Arthritis | Pain Products

Posted by Asebey Law

FDA is notifying consumers of certain products promoted for arthritis and pain management that have been found to contain hidden ingredients and may pose a significant health risk. Read More (external link)...

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31 October

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ITCHA XS may be harmful due to hidden drug ingredients

Posted by Asebey Law

ITCHA XS may be harmful due to hidden drug ingredients Read More (external link)...

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31 October

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Incubator/Warmer Correction: GE Healthcare Updates Use Instructions for Giraffe OmniBed and Giraffe Omnibed CareStation due to Risk of Heater Door Falling and Causing Infant Injury

Posted by Asebey Law

The heater door of Giraffe Omnibed, CareStation infant incubators/ warmers may fall off if instructions are not followed, potentially injuring patients. Read More (external link)...

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30 October

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Outbreak Investigation of E. coli O157:H7: Onions (October 2024)

Posted by Asebey Law

The FDA, U.S. Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS), and Centers for Disease Control and Prevention (CDC), in collaboration with state and local partners, are investigating illnesses in a multistate outbreak of E. coli O157:H7 infections. Read More (external link)...

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30 October

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Florida Company Pleads Guilty to Conspiring to Sell Misbranded N95 Masks to Hospital in Early Months of COVID-19 Pandemic

Posted by Asebey Law

FDA-OCI, JDM Supply LLC, Daniel Motha, Jeffrey Motha Read More (external link)...

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29 October

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California Company Charged with Conspiring to Sell Misbranded N95 Masks to Hospital in Early Months of COVID-19 Pandemic

Posted by Asebey Law

FDA-OCI, JDM Supply LLC, Advoque Safeguard LLC, Santa Cruz, California, Jason Azevedo, Paul Shrater, Andrew Stack Read More (external link)...

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29 October

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Update: Use of GE HealthCare EVair and EVair 03 Compressors – Letter to Health Care Providers

Posted by Asebey Law

The recommendations for EVair Compressor use have been updated by GE HealthCare. Read More (external link)...

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29 October

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Air Compressor Device Correction: GE HealthCare Provides Updates to EVair Compressors Due to Final Formaldehyde Testing Results

Posted by Asebey Law

These air compressor devices’ instructions for use have been updated by GE HealthCare. Read More (external link)...

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29 October

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2024 Letters to Health Care Providers

Posted by Asebey Law

The FDA posts letters to health care providers about the safe use of medical devices. Read More (external link)...

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28 October

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Physician Charged in Scheme to Illegally Sell Cancer Drugs

Posted by Asebey Law

FDA-OCI, Eastern District of Michigan, Detroit, Michigan, Dr. Naveed Aslam Read More (external link)...

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28 October

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Dynarex Corporation Expands Recall to Include Additional Products Due to Possible Health Risk

Posted by Asebey Law

Dynarex Corporation is expanding the recall initiated on September 19, 2024, to include an additional 373 cases of item number 4875, Dynacare Baby Powder, 14 oz., as well as 647 cases of item number 4874, Dynacare Baby Powder, 4 oz., because they have the potential to be contaminated with asbestos. Read More (external link)...

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28 October

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Atwater’s Issues Allergy Alert on Undeclared Tree Nuts in “Spider Web Tart”

Posted by Asebey Law

Atwater’s of Baltimore, MD, is recalling its clam shell packages of spider web tarts sold 10/19/24 and 10/20/24 because they contain undeclared almond flour. People who have allergies to tree nuts run the risk of a serious or life-threatening allergic reaction if they consume these products. Read More (external link)...

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26 October

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Fresh Express is Voluntarily Recalling a Limited Number of Gourmet Café Chicken Caesar Salad Bowls

Posted by Asebey Law

Fresh Express is voluntarily recalling a limited number of Gourmet Café Chicken Caesar Salad Bowls due to the inclusion of recalled chicken items from BrucePac, an outside ingredient supplier. The BrucePac recall is due to possible Listeria monocytogenes contamination. The fresh vegetable components Read More (external link)...

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25 October

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Acme Smoked Fish Corporation Recalls Kirkland Signature Smoked Salmon Due to Listeria Monocytogenes Contamination

Posted by Asebey Law

Acme Smoked Fish Corporation is issuing a recall of 111 cases of Kirkland Signature Smoked Salmon in twin 12oz package, UPC 0 96619 25697 6, Lot# 8512801270, Best-by-Date 11/13/2024 due to laboratory testing confirming Listeria monocytogenes on October 21, 2024. Listeria monocytogenes, an organism w Read More (external link)...

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