The U.S. Food and Drug Administration is warning consumers that the agency continues to receive adverse event reports related to selective androgen receptor modulators, commonly called SARMs. Social media posts by influencers and sellers of SARMs contribute to the availability and promotion of these dangerous products. Targeting teenagers and young adults, videos on social media…
2023 Medical Device Recalls
Fresenius Kabi USA, LLC Recalls Ivenix Infusion System for Fluid Leak That May Delay or Interrupt Treatment 04/19/2023 Philips Respironics Recalls Certain Reworked DreamStation CPAP, BiPAP Machines for the Risk They May Deliver Inaccurate or Insufficient Therapy 04/07/2023 Abbott Recalls the Readers used with the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2…
Avanos Medical Inc Recalls Certain BALLARD ACCESS Closed Suction Systems for Neonates/Pediatrics for Risk of Inadequate Ventilation, Other Injuries from Cracked Manifolds
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: BALLARD ACCESS Closed Suction System for Neonates/Pediatrics with Y-Manifold; BALLARD ACCESS Closed Suction System for Neonates/Pediatrics with Elbow Manifold Product Stock Codes: Distribution Dates: October…
FDA D.I.S.C.O. Burst Edition: FDA approval of Zynyz (retifanlimab-dlwr) for metastatic or recurrent locally advanced Merkel cell carcinoma
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 March 22, 2023, the FDA granted accelerated approval to…
Fresenius Kabi USA, LLC Recalls Ivenix Infusion System for Fluid Leak That May Delay or Interrupt Treatment
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: Ivenix Infusion System Model: LVP-0004 Devices Recalled in the U.S.: 1,546 Dates Distributed: October 27, 2021 – January 30, 2023 Date Initiated by Firm: March…
All Opioid Pain Medicines: Drug Safety Communication – FDA Updates Prescribing Information to Provide Additional Guidance for Safe Use
[Posted 04/13/2023] AUDIENCE: Patient, Health Professional, Pain Management, Pharmacy, Caregivers ISSUE: The FDA is requiring several updates to the prescribing information for both immediate-release (IR) and extended release/long acting (ER/LA) opioid pain medicines. This includes stating for all opioid pain that the risk of overdose increases as the dose increases. The updates to IR opioids state these…
Understanding the Regulatory Terminology of Potential Preventative and Therapeutic Drugs for COVID-19
Image Español 简体中文 한국어 Tagalog Việt Scientists continue to work on developing potential drugs for the prevention and treatment of COVID-19. The language used to describe potential drugs can be confusing. Here’s what some of those terms mean. What “FDA Approved” Means Consumers rely on the U.S. Food and Drug Administration to…
Risk of Protection Failure with Certain O&M Halyard Surgical N95 Respirators, Surgical Masks, and Pediatric Face Masks: FDA Safety Communication
Date Issued: April 12, 2023 The U.S. Food and Drug Administration (FDA) is recommending consumers, health care providers, and facilities to not use certain surgical N95 respirators manufactured by O&M Halyard, and to use caution with certain surgical masks and pediatric face masks manufactured by O&M Halyard. The FDA is aware of laboratory test results…
Actualización sobre reportes de carcinoma de células escamosas en la cápsula alrededor de los implantes de seno: Comunicado de seguridad de la FDA
English Fecha de publicación: 8 de marzo de 2023 La Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) está proporcionando una actualización sobre los reportes de carcinoma de células escamosas (SCC, por sus siglas en inglés) en el tejido cicatricial (cápsula) que se forma alrededor de los implantes…
Philips Respironics Recalls Certain Reworked DreamStation CPAP, BiPAP Machines for the Risk They May Deliver Inaccurate or Insufficient Therapy
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: Philips Respironics DreamStation1 (Uno Remediated Devices) Product Models: REP DreamStation Auto CPAP Recert, DreamStation Auto, FR REP DreamStation Auto BiPAP, DOM-RECRT, and REP DreamStation Auto…