CGMP/Finished Pharmaceuticals/Adulterated
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A newsletter on regulatory science for CDER’s stakeholdersEarly Alert: Anesthesia System Issue from GE HealthCare
GE HealthCare issues updated use instructions for certain Carestation 600 and 700 series Anesthesia SystemsCOSMO KOREA – 11/03/2025
Unapproved New Drugs/Misbranded/BotoxMahita LLC dba PushMyCart – 716286 – 11/17/2025
Unapproved New DrugsPeakMax may be harmful due to hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use PeakMax, a product promoted and sold for sexual enhancement on various websites, including www.vitalityvita.com, and possibly in some retail stores.PlantBased Innovations Issues Allergy Alert on Undeclared Almond in H-E-B Dairy-Free Coconut Yogurt, Strawberry Flavor
PlantBased Innovations, of Leominster, MA, is recalling Higher Harvest by H-E-B Dairy-Free Coconut Yogurt, Strawberry flavor because the product may contain undeclared almond. People who have an allergy or severe sensitivity to almonds run the risk of serious or life-threatening allergic reaction if
