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…
Umary contains hidden drug ingredients
[6-14-2024] The Food and Drug Administration is advising consumers not to purchase or use Umary, a product promoted and sold for pain on various websites, including https://www.solovital.com and possibly in some retail stores. FDA laboratory analysis confirmed that Umary contains diclofenac and omeprazole, which are not listed on the product label. Diclofenac is a non-steroidal anti-inflammatory…
La Paix contains hidden drug ingredient
[6-14-2024] The Food and Drug Administration is advising consumers not to purchase or use La Paix, a product promoted and sold for sexual enhancement on various websites, and possibly in some retail stores. This product was discovered during an examination of imported goods. FDA laboratory analysis confirmed that La Paix contains sildenafil, the active ingredient…
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…
Heinen’s Issues Allergy Alert on Undeclared Pecans in Heinen’s Tuscan Salad Bowls
Summary Company Announcement Date: May 30, 2024 FDA Publish Date: June 14, 2024 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared Pecans Company Name: Heinen’s Inc. Brand Name: Brand Name(s) Heinen’s Product Description: Product Description Tuscan Salad Bowl Company Announcement May 30th, 2024. Heinen’s of Warrensville Heights, OH is voluntarily…
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…
Villa Nueva Interservices LLC Issues Allergy Alert on Undeclared Milk in “Arepas LA Mejor” 25 oz Bags of Arepa de Choclo /Chocolo
Summary Company Announcement Date: June 11, 2024 FDA Publish Date: June 13, 2024 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Villa Nueva Interservices LLC Brand Name: Brand Name(s) Arepas La Mejor Product Description: Product Description Company Announcement Villa Nueva Interservices LLC. in Lake Worth, FL is…