FDA News

16 October

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C&A Naturistics Issues Voluntary Nationwide Recall of AK Forte Tablets con Ortiga y Omega 3 Due to the Presence of Undeclared Drug Ingredients: Diclofenac, Dexamethasone, and Methocarbamol

Posted by Asebey Law

10/8/24 – National City, CA, C&A Naturistics is voluntarily recalling all lots of AK Forte, 400 mg tablets, to the consumer level. FDA analysis has found the product to be tainted Diclofenac, Dexamethasone, and Methocarbamol. Products containing diclofenac, dexamethasone, and methocarbamol cannot b Read More (external link)...

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11 October

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Enoki King Mushroom Farm Recalls Enoki Because of Possible Health Risk

Posted by Asebey Law

Enoki King Mushroom Farm of Ventura, CA is recalling lot 4877 of its 5.3-ounce (150g) packages of Enoki Mushroom (Product of USA) 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 o Read More (external link)...

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11 October

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Tipical Latin Food, Corp. Issues Allergy Alert on Undeclared Wheat in Cachapa de Maiz

Posted by Asebey Law

TIPICAL LATIN FOOD CORP of Miami, FL is recalling Cachapa de Maiz sweet corn pancakes labeled under Los Andes Foods, because it may contain undeclared wheat. People who have an allergy or severe sensitivity to run the risk of serious or life-threatening allergic reaction if they consume these produc Read More (external link)...

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11 October

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$2,125,640 Recouped in Civil Settlements for Violations of the False Claims Act from Local Pharmacies in Cidra and Florida, Puerto Rico

Posted by Asebey Law

FDA-OCI, San Juan, Cidra, Florida, Puerto Rico, Farmacia Beatriz, Edwin Valentin-Rosario, CDT Policlínica Familiar Florida, Jesús Vázquez Read More (external link)...

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11 October

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Infusion Pump Recall: Zyno Medical Removes Z-800, Z-800F, Z-800W, and Z800WF Infusion Pumps due to an Air-in-Line Software Defect That May Allow Larger than Expected Air Bubbles to Enter Patients

Posted by Asebey Law

Zyno Medical Z-800 infusion pumps allow for infusions through the blood vessels but a software defect may allow air bubbles to enter the patient. Read More (external link)...

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10 October

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Reser’s Fine Foods Announces Voluntary Recall of Limited Number of Meal Kits Due to Recalled Chicken from Ingredient Supplier (BrucePac)

Posted by Asebey Law

Out of an abundance of caution, Reser’s Fine Foods is voluntarily recalling a limited number of meal kits due to the inclusion of recalled chicken from an outside ingredient supplier (BrucePac). The ingredient supplier (BrucePac) recall is due to possible Listeria monocytogenes contamination. Read More (external link)...

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10 October

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Magellan Diagnostics Sentenced for Concealing Malfunction in Lead Testing Devices

Posted by Asebey Law

FDA-OCI, Magellan Diagnostics, District of Massachusetts, Billerica, Massachusetts, LeadCare Ultra, LeadCare II Read More (external link)...

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10 October

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Wismettac Asian Foods Issues Allergy Alert on Undeclared Sesame in Seasoned Seaweed

Posted by Asebey Law

Wismettac Asian Foods, Inc., Santa Fe Springs, CA is recalling 3.52 oz packages of Shirakiku brand Korean Seasoned Seaweed. The product contains the undeclared allergen of sesame on an outer package. People who have an allergy or severe sensitivity to sesame run the risk of serious or life-threateni Read More (external link)...

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09 October

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Outbreak Investigation of Listeria monocytogenes: Queso Fresco and Cotija Cheese (February 2024)

Posted by Asebey Law

The FDA and CDC, in collaboration with state and local partners, are investigating illnesses in a multistate outbreak of Listeria monocytogenes infections linked to aged cotija cheese from Rizo Lopez Foods, Inc., of Modesto, California. Read More (external link)...

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08 October

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Former Nurse Pleads Guilty in Connection with Diverting Fentanyl from ICU Patient

Posted by Asebey Law

FDA-OCI, District of New Hampshire, Concord, Northfield, New Hampshire, Lisa Richardson, Concord Hospital Read More (external link)...

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07 October

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

Posted by Asebey Law

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

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07 October

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Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitators due to Risk of Inline Controller Detachment that May Impact Ventilation

Posted by Asebey Law

Neo-Tee Resuscitators are used for emergency breathing support for neonates and infants. The inline controller may come apart and impact ventilation. Read More (external link)...

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07 October

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Philips Respironics Issues Additional Usage Instructions for Trilogy Evo Ventilators Related to Use of In-Line Nebulizers

Posted by Asebey Law

The use of in-line nebulizers placed in certain locations may lead to aerosol deposits forming over time on the ventilator flow sensor. Should this occur, there is a possibility of inaccurate flow measurements affecting therapy. Read More (external link)...

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04 October

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Jacks and the Green Sprouts Recalls Alfalfa and Alfalfa Onion Sprouts Because of Possible Health Risk

Posted by Asebey Law

Jack and the Green Sprouts, Inc. of River Falls, WI is recalling its 5 ounce packages of Alfalfa and Alfalfa Onion sprouts 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 el Read More (external link)...

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04 October

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Lunds & Byerlys Voluntarily Recalls L&B Lone Star Dip Due to Potential Mold

Posted by Asebey Law

Edina, Minn. (October 4, 2024) – Lunds & Byerlys is voluntarily recalling approximately 500 containers of L&B Lone Star Dip because of potential mold growth contamination. The recalled product was sold at Lunds & Byerlys stores throughout the Twin Cities and surrounding area. Read More (external link)...

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04 October

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Ten Pharmaceutical Distributor Executives, Sales Representatives, and Brokers Charged in Connection with Unlawful Sales of Nearly 70M Opioid Pills

Posted by Asebey Law

Ten Pharmaceutical Distributor Executives, Sales Representatives, and Brokers Charged in Connection with Unlawful Sales of Nearly 70M Opioid Pills. Largest Ever Criminal Enforcement Action Targeting Distributors of Pharmaceutical Opioids and Commonly Abused Prescription Drugs worth $1.3 billion. Read More (external link)...

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04 October

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Youngstown Grape Distributors Inc. Recalls Happy Moose Juice Tropical Roots and Happy Moose Strawberry Fields Because of Possible Health Risk

Posted by Asebey Law

Youngstown Grape Distributors Inc., a co-manufacturer for Happy Moose Juice, is voluntarily recalling Happy Moose Tropical Roots Juice (Lot# H240903-E BEST BY 12/02/2024) and Happy Moose Strawberry Fields (Lot# H240903-H, BEST BY 12/02/2024) because a portion of the production made did not complete Read More (external link)...

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02 October

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Public Notification: Body Shape Weight Loss System contains hidden drug ingredients

Posted by Asebey Law

The Food and Drug Administration is advising consumers not to purchase or use Body Shape Weight Loss System, a product promoted for weight loss. This product was identified during an examination of imported goods. Read More (external link)...

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02 October

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IPV Therapy Device Correction: Sentec/Percussionaire Updates Use Instructions for Phasitron 5 In-Line Valve to Prevent Accidental Misuse of Expiratory Port Plug

Posted by Asebey Law

IPV Phasitron 5 In-Line Valve helps provide therapy to promote ventilation. Users need to remove the expiratory port plug before direct ventilation. Read More (external link)...

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01 October

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Founder and Chief Executive Officer of Injectable Stem Cell Product Manufacturer Sentenced for Distributing Unapproved Drug

Posted by Asebey Law

FDA-OCI, Orange County, California, John W. Kosolcharoen, Liveyon LLC, Genetech Inc. Read More (external link)...

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