[embedded content] Español Is It Really “FDA Approved”? Part 2. Here are 10 more facts about how the FDA works to protect public health. Fact #11: The FDA regulates dermal fillers as medical devices. Dermal fillers are gel-like substances injected under the skin to create a smoother or fuller appearance in the lips, face, or back of…
Food
PDF Version (522 KB) Español The scope of FDA’s regulatory authority is very broad. FDA’s responsibilities are closely related to those of several other government agencies. Often frustrating and confusing for consumers is determining the appropriate regulatory agency to contact. The following is a list of traditionally-recognized product categories that fall under FDA’s regulatory jurisdiction;…
FDA D.I.S.C.O. Burst Edition: FDA approval of Ojemda (tovorafenib) for relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval. On April 23, 2024, the FDA granted accelerated approval to…
Endotracheal Tube Recall: Medline Industries, LP Removes Medline Sub-G Endotracheal Tube with Subglottic Suctioning due to Detachment or Tearing of the Inflation Tube from the Main Tube
This recall involves removing devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Names: Medline Sub-G Endotracheal Tube with Subglottic Suctioning Unique Device Identifier (UDI)/Model: This recall includes…
Getinge Recalls Vaporizer Sevoflurane Maquet Filling for Risk of Patient and Health Care Professional Exposure to Toxic Chemical Hydrogen Fluoride
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: Vaporizer Sevoflurane Maquet Filling Product Code: 6682282 Distributed Serial Numbers: 17003 – 23454 Devices Recalled in the U.S.: 120 Dates Distributed: February 2, 2022 to…
Teleflex/Arrow International Recall Arrow FiberOptix and UltraFlex Intra-Aortic Balloon (IAB) Catheter Kits for Manufacturing Issue That May Prevent Full Balloon Inflation and Cause Patient Harm
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Please be aware, this recall is a correction, not a product removal. Recalled Product Product Name: Arrow FiberOptix Intra-Aortic Balloon (IAB) Catheter Kit and Arrow UltraFlex Intra-Aortic Balloon Catheter…
Electrode Pad Recall: Megadyne Removes MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes for Risk of Serious Burn Injuries to Patients
This recall involves removing devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Figure 1: MEGADYNE MEGA SOFT Pediatric Patient Return Electrode Product Name: MEGADYNE MEGA SOFT Pediatric Patient…
Suntegrity Skincare Issues Voluntary Recall of Suntegrity Impeccable Skin Sunscreen Foundation (Multiple Shades) Due to Microbial Contamination
Summary Company Announcement Date: June 11, 2024 FDA Publish Date: June 12, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Higher than acceptable microbiological mold count Company Name: Suntegrity Skincare Brand Name: Brand Name(s) Suntegrity Product Description: Product Description Sunscreen foundation Company Announcement FOR IMMEDIATE RELEASE – Jun 11, 2024 – Las Vegas,…
Male Enhancement Supplements Recalled
Summary Company Announcement Date: February 01, 2024 FDA Publish Date: June 11, 2024 Product Type: Dietary SupplementsDrugs Reason for Announcement: Recall Reason Description Product is tainted with sildenafil and tadalafil Company Name: Integrity Products Brand Name: Brand Name(s) Ram It, To The Moon Product Description: Product Description Dietary Supplements for Male Sexual Enhancement Company Announcement…
HomeoCare Laboratories Inc. Issues Voluntary Nationwide Recall of Homeopathic Stella Life Oral Care Spray Unflavored and Advanced Formula Peppermint Oral Care Rinse Due to Microbial Contamination
Summary Company Announcement Date: June 05, 2024 FDA Publish Date: June 05, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination Company Name: HomeoCare Laboratories Inc. Brand Name: Brand Name(s) StellaLife Inc. Product Description: Product Description Homeopathic StellaLife Oral Care Products Company Announcement FOR IMMEDIATE RELEASE – Yonkers, NY, 06/05/2024 – HomeoCare…