FDA News Archives - Page 15 of 20

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

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)...

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

in FDA News

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)...

02 October

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

Posted by Asebey Law

in FDA News

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)...

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

in FDA News

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)...

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

in FDA News

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

01 October

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South Florida U.S. Attorney’s Office Charges an Attorney, Former SBA Employee, Tax Preparer, and others with COVID-19 Fraud Schemes

Posted by Asebey Law

in FDA News

FDA-OCI, Miami, Florida, Southern District of Florida, U.S. v. Nabil Nahlah, Case No. 24-CR-20434, Nabil Nahlah, SkyMed Gloves Read More (external link)...

01 October

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Infusion Pump Software Correction: Fresenius Kabi USA, LLC, Issues Correction for Ivenix Infusion System Large Volume Pump (LVP) Software due to Multiple Anomalies that May Cause Delay or Underdosage of Therapy

Posted by Asebey Law

in FDA News

Ivenix LVP allows for controlled administration of large volumes of fluids but software anomalies may lead to delay or underdosing of therapy. Read More (external link)...

01 October

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Ventilator Software Correction: Philips Respironics Issues Mandatory Software Correction and Updates Use Instructions for Trilogy Evo, EV300, EvoO2, and Evo Universal to Address Multiple Issues that May Impact Ventilation

Posted by Asebey Law

in FDA News

Trilogy Evo, EV300, EvoO2 and Evo Universal ventilators support patient breathing. A mandatory software correction was issued to address previously reported issues. Read More (external link)...

30 September

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Ventilator Correction: Smiths Medical Issues Correction for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal Volume Knob Movement

Posted by Asebey Law

in FDA News

paraPAC Plus P300 and P310 Ventilators are gas-powered emergency and transport portable ventilators. The tidal volume knob may move out of the set position. Read More (external link)...

27 September

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27 Individuals Indicted for Buying and Selling Wholesale Quantities of Misbranded and Diverted Prescription Drugs Resold to the Public Through Retail Pharmacies in Puerto Rico

Posted by Asebey Law

in FDA News

FDA-OCI, District of Puerto Rico, San Juan, Bayamón, Aibonito, Canóvanas, Luquillo, Puerto Rico, HHS OIG, Farmacia Monte Verde, Farmacia Santa Olaya, Farmacia Unity, Farmacia San Antonio, Farmacia Brisas del Mar, Read More (external link)...

24 September

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Truly Good Foods Issues Allergy Alert on Undeclared Almonds and Cashews in Grabeez The Big Cheese Snack Mix 3.25 oz Cup

Posted by Asebey Law

in FDA News

Truly Good Foods is recalling its 3.25-ounce packages of Grabeez The Big Cheese Snack Mix cups with a Best Before 041625 because they contain undeclared almonds and cashews. People who have allergies or severe sensitivity to almonds and cashews run the risk of serious or life-threatening allergi Read More (external link)...

24 September

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Compounding Device Inlet Correction: Baxter Healthcare Corporation Updates Use Instructions for Exactamix Automated Compounding Device Inlets due to Risk for Particulate Matter in Device Components

Posted by Asebey Law

in FDA News

Automated Compounding Device Inlets used with Exactamix Compounding Devices may contain particulate matter that poses a risk to patients. Read More (external link)...

23 September

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Former Nurse Sentenced for Tampering with Oxycodone

Posted by Asebey Law

in FDA News

FDA-OCI, Boston, Dedham, Massachusetts, Jaclyn McQueen Read More (external link)...

23 September

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Megadyne Medical Products, Inc. Recalls Mega Soft Universal Patient Return Electrode Due to Reports of Patient Burns

Posted by Asebey Law

in FDA News

Megadyne is updating the instructions and product labeling to reflect that the Mega Soft Universal pads should not be used in patients under 12 years old. Read More (external link)...

23 September

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Gilead Issues Voluntary Nationwide Recall of One Lot of Veklury (Remdesivir) for Injection 100 mg/vial Due to the Presence of a Glass Particle

Posted by Asebey Law

in FDA News

Foster City, Calif., September 20, 2024 - Gilead Sciences, Inc. (Nasdaq: GILD) today announced it is issuing a voluntary recall of one lot of Veklury® (remdesivir) for Injection 100 mg/vial, to the consumer level. Gilead received a customer complaint and confirmed the presence of a glass particle in Read More (external link)...

23 September

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Electrode Pad Correction: Megadyne Issues Correction for MEGA SOFT, MEGA SOFT DUAL and MEGA 2000 Patient Return Electrodes to Limit Risk of Pediatric Burns

Posted by Asebey Law

in FDA News

MEGA SOFT and MEGA 2000 Patient Return Electrodes used during monopolar electrosurgery may cause serious patient burn injuries. Read More (external link)...

22 September

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ANSWERS Pet Food Voluntarily Withdrawals Certain Limited Lots of Beef and Chicken Dog Foods Due to Potential Salmonella and Listeria

Posted by Asebey Law

in FDA News

Lystn, LLC d.b.a./ANSWERS Pet Food of Fleetwood, PA, is voluntarily withdrawing certain lots of ANSWERS Detailed Beef Formula for Dogs, ANSWERS Straight Beef Formula for Dogs, and ANSWERS Straight Chicken Formula for Dogs out of an abundance of caution after samples collected by the U.S. Food and Dr Read More (external link)...

22 September

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Avole Inc. Emite Aviso de Retiro del Mercado su Producto Bacalaitos Criollos Mezcla para Freír Bacalao por Falta de Declaración del Nombre Común Pescado (Pollock)

Posted by Asebey Law

in FDA News

Avole Inc., localizado en San Sebastián, Puerto Rico está retirando del mercado fundas de 7 onzas de Bacalaitos Criollos Mezcla para freír Bacalao, porque pueden contener falta de declaración del nombre común Pescado (Pollock) en la declaración de ingredientes o contenido. Las personas que tienen al Read More (external link)...

20 September

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Grace Imports, LLC Issues Allergy Alert of Undeclared Wheat in Kara Boondh, Kerala Mixture and Spicy Murukku

Posted by Asebey Law

in FDA News

Grace Imports, LLC., of Tucker, GA - September 20, 2024, is voluntarily recalling 250g bags of Kara Boondhi, Batch No. 2Al488 UPC 8 904123 53706, 300g bags of Kerala Mixture, Batch No. 2Al564 UPC 8 904123 500329 and 250g bag Spicy Murukku Batch No. 2Al504 UPC 8 904123 because these products contain Read More (external link)...

20 September

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HP Hood LLC Recalls Select Units of 96 oz Refrigerated Lactaid Milk Due to Possible Almond Allergen

Posted by Asebey Law

in FDA News

HP Hood LLC is recalling five SKUs of 96 oz containers of LACTAID Milk because the product may contain trace amounts of almond, which is not listed on the label. People who have an allergy or severe sensitivity to almonds may run the risk of serious or life-threatening allergic reaction if they cons Read More (external link)...