Pharma & Life Sciences

Boston Scientific Recalls AXIOS Stents Due to Deployment Issues

The FDA is alerting the public about a recall of Boston Scientific AXIOS Stents and Electrocautery Enhanced Delivery Systems due to issues with stent deployment. The recall has been identified as the most serious type, with 167 injuries and 3 deaths reported. Healthcare providers are instructed to immediately stop distribution or use of affected devices.

Go Raw LLC Recalls Cat Food Due to Low Thiamine

Go Raw LLC is voluntarily recalling one lot of Quest Cat Food Chicken Recipe Freeze Dried Nuggets due to low thiamine levels. The recall was initiated after one report of illness in a cat, which has since recovered. Consumers are advised to stop feeding the product and return it for a refund.

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.