Listing of Medical Device 2024 Safety Communications
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Pure Indulgence Aesthetics – 12/12/2025. Country: United States. Record Type: 483Update: FDA Encourages the Public to Follow Established Choking Rescue Protocols – FDA Safety Communication
These choking rescue protocols include abdominal thrusts (also called the “Heimlich” maneuver) for children and adults but not anti-choking devices.Impact Stories
Stories illustrating how regulatory science impacts the lives and health of peopleEndo Expands Voluntary Recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) Due to Potential Product Carton Strength Mislabeling
Endo, Inc. (OTCQX: NDOI) (“Endo”) announced today that one of its operating subsidiaries, Endo USA, Inc., is expanding its previously announced voluntary recall of Clonazepam Orally Disintegrating Tablets, USP (C-IV) due to potential product carton strength mislabeling.Thea Pharma, Inc. – 712416 – 07/09/2025
Unapproved New Drugs/MisbrandedEndothelin Receptor Antagonist REMS Information
FDA has determined that a REMS is no longer necessary to ensure ERA medicines’ benefits outweigh the risk of EFT.
