FDA News

18 October

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Dakota Tom’s Sandwiches Recalls Pepperjack Cheeseburger, Bacon Cheeseburger and The Gambler Because of Possible Health Risk

Posted by Asebey Law

Dakota Tom’s Sandwiches Corsica, SD is voluntarily recalling our Pepperjack Cheeseburger, Bacon Cheeseburger and The Gambler due to the burger patty being included in a recall from an outside supplier (BrucePac). The ingredient supplier (BrucePac) recall is due to possible Listeria monocytogenes con Read More (external link)...

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18 October

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Vascular Embolization Device Correction: Boston Scientific Updates Use Instructions for Obsidio Conformable Embolic for Increased Ischemia Risk When Used for GI Bleeding

Posted by Asebey Law

These vascular embolization devices’ instructions for use have been updated by Boston Scientific. Read More (external link)...

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18 October

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Voluntary Recall Notifying Medtronic Insulin Pump Users of Potential Risks of Shortened Pump Battery Life

Posted by Asebey Law

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, voluntarily issued a field action starting on July 31, 2024, notifying global customers of its MiniMed™ 600 series or 700 series insulin pumps to follow their pump’s built-in alerts and alarms for battery status and to contact Medt Read More (external link)...

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17 October

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Insulin Pump Recall: Medtronic Notifies Users of MiniMed 600 and 700 Series Pumps of Risk of Shorter than Expected Battery Life

Posted by Asebey Law

MiniMed pumps deliver insulin to people with diabetes who need it. Wiring damage from impacts may cause the battery to drain faster than expected. Read More (external link)...

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16 October

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Houston man guilty in $160M Medicare fraud scheme

Posted by Asebey Law

FDA-OCI, Mohamad Mokbel, 4M Pharmaceuticals, OptumRx, Medicare fraud, Houston, Texas Read More (external link)...

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16 October

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UPDATE: Do Not Use Cue Health’s COVID-19 Tests Due to Risk of False Results: FDA Safety Communication

Posted by Asebey Law

The FDA issues alert about risk of false results with Cue Health’s COVID-19 Tests due to modifications made without FDA authorization that have a strong likelihood to impact performance. Read More (external link)...

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16 October

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Staska Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL Due to the Presence of Glass Particles

Posted by Asebey Law

Bennet, NE, STASKA PHARMACEUTICALS, INC. is voluntarily recalling 1 lot of Ascorbic Acid Solution for Injection (Preservative Free, Non-Corn) 500mg/mL, 50mL vials to the user level. This is due to the presence of glass particulates in one lot of vials used in the production of this batch. Read More (external link)...

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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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