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457 changes

8d ago FDA Warning Letters
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FDA Warning Letter to Good Girl LLC for False Claims

The FDA issued a warning letter to Good Girl LLC (dba GoodGirlRX) for making false and misleading claims on its website regarding compounded semaglutide and tirzepatide products. The company claimed the products were 'FDA-approved' and that GoodGirl RX was the compounder, which the FDA states is false and misbrands the drugs.

Urgent Enforcement Pharmaceuticals
8d ago FDA Warning Letters
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FDA Warning Letter to Lean Rx Inc. dba SkinnyRx

The FDA issued a warning letter to Lean Rx Inc. dba SkinnyRx for misbranding compounded semaglutide and tirzepatide products. The agency cited false or misleading claims on the company's website regarding the compounding of these drugs and their relation to FDA-approved medications.

Urgent Enforcement Pharmaceuticals
8d ago FDA Warning Letters
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FDA Warning Letter to Peaks Curative for False Claims

The FDA issued a warning letter to Peaks Curative, LLC for making false and misleading claims on its website regarding compounded semaglutide products. The agency found that the company misrepresented its compounding practices and implied FDA approval for products that are not FDA-approved, leading to misbranding violations.

Urgent Enforcement Pharmaceuticals
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Health District Promotes Colon Cancer Prevention

The Rappahannock-Rapidan Health District has issued a notice encouraging healthy behaviors and early screenings to prevent colon cancer during National Colon Cancer Awareness Month. The notice highlights lifestyle risk factors and recommends screenings starting at age 45 for average-risk adults.

Routine Notice Public Health
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Transport Canada Truck Recall - Electrical Issue

Transport Canada has issued a recall for certain Western Star and Freightliner trucks due to an improperly installed tarp system relay that poses a fire risk. Owners will be notified by mail to inspect and potentially reinstall the relay.

Urgent Notice Transportation
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Ford Escape, Bronco Sport Recall - Fuel Injector Crack

Transport Canada has issued a recall for certain 2020-2022 Ford Escape and Bronco Sport vehicles due to a potential fuel injector crack, which could lead to a fuel leak and fire risk. Ford will notify owners to update software and install a drain tube, with an extended warranty for injector replacement.

Urgent Enforcement Transportation
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Ford SUV Recall - Fuel Injector Leak Risk

Transport Canada has issued recall 2024160 for certain 2022-2023 Ford Escape and Bronco Sport models due to a risk of fuel leaks from cracked fuel injectors, which could lead to engine compartment fires. Ford will notify owners to update software and install a drain tube, with an extended warranty for injector replacement.

Urgent Notice Transportation
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Integra LifeSciences Recalls MediHoney and CVS Wound Dressings

The FDA announced a recall initiated by Integra LifeSciences for certain MediHoney and CVS Wound Gel products due to packaging failures that could lead to infection or delayed care. The recall involves removing affected products from service and distribution. Integra LifeSciences has reported 11 serious injuries related to MediHoney and three related to CVS Wound Gel.

Urgent Enforcement Medical Devices
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California CDPH Advises Public to Avoid Sick Wildlife Due to H5N1 Bird Flu

The California Department of Public Health (CDPH) issued a notice urging the public to avoid contact with sick or dead wildlife after H5N1 bird flu was confirmed in northern elephant seal pups. The agency emphasizes a low risk to the public but advises caution and reporting of sick animals.

Priority review Notice Public Health
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MHRA Class 2 Recall: Crescent Pharma Ramipril 5mg Capsules

The MHRA has issued a Class 2 medicines recall for one batch of Crescent Pharma Limited's Ramipril 5mg Capsules due to a manufacturing error where incorrect blister strips were found in the packaging. Healthcare professionals are instructed to stop supplying the affected batch immediately and contact patients who received the product.

Urgent Enforcement Pharmaceuticals

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