Recent changes
Made Fresh Salads Recalls Cream Cheese for Listeria Contamination
Made Fresh Salads, Inc. is recalling assorted flavors of cream cheese due to potential contamination with Listeria monocytogenes. The recall was initiated after the company's own sampling revealed contamination from a mixer. No illnesses have been reported to date.
Saputo USA Recalls Great Value Cottage Cheese Due to Health Risk
Saputo USA is recalling Great Value cottage cheese sold at Walmart due to potential under-pasteurization, posing a health risk. The FDA is aware of the recall, which affects products distributed in multiple states. Consumers are advised to return affected products for a refund.
Elite Treats Recalls Chicken Chips for Salmonella Contamination
Elite Treats, LLC. is recalling a single lot of chicken dog treats due to potential Salmonella contamination. The recall impacts products sold to feed stores in Alabama, Florida, Georgia, North Carolina, and South Carolina. No illnesses have been reported to date.
Lockout Supplements Recalls Chocolate Syrup for Undeclared Sildenafil
Lockout Supplements is voluntarily recalling all lots of Boner Bears Chocolate Syrup nationwide due to undeclared sildenafil. The undeclared ingredient poses a risk of dangerous blood pressure reduction when interacting with prescribed medications.
EMA Recommends Six New Medicines for Approval
The European Medicines Agency's CHMP has recommended six new medicines for marketing authorisation and nine for extension of therapeutic indications. These recommendations cover treatments for various conditions including menopausal symptoms, liver disease, a rare genetic disorder, influenza, and graft-versus-host disease.
EMA Recommends Kygevvi for Rare TK2d Disease Treatment
The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Kygevvi, a new treatment for the rare genetic disease thymidine kinase 2 deficiency (TK2d). This recommendation is based on clinical study data showing improvement in motor function for pediatric patients.
EMA Recommends Withdrawal of Levamisole Medicines
The European Medicines Agency (EMA) recommends the withdrawal of marketing authorisations for medicines containing levamisole due to the serious side effect of leukoencephalopathy. This recommendation follows an EU-wide review concluding that the benefits of these medicines no longer outweigh their risks for treating parasitic worm infections.
Levamisole withdrawn from EU market due to leukoencephalopathy risk
The EMA's PRAC has recommended the withdrawal of marketing authorisations for all medicines containing levamisole from the EU market. This decision is due to the confirmed risk of leukoencephalopathy, a serious brain side effect, where the benefits of the medicine no longer outweigh the risks for treating parasitic worm infections.
CVMP Opinions and Guidelines Update
The EMA's Committee for Veterinary Medicinal Products (CVMP) adopted positive opinions for several variations to existing veterinary medicinal products and discussed pharmacovigilance signals. These updates primarily involve product information changes based on signal management processes.
MHRA Raids Illegal Weight Loss Medicine Facility
The MHRA has raided two facilities suspected of manufacturing and selling illegal weight loss medicines, seizing nearly 2,000 doses and manufacturing equipment. This action is part of an ongoing investigation into a criminal network and aims to protect the public from dangerous, unregulated products.
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