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…
Suburban Nurse Pleads Guilty to Tampering with Patient Medications
Department of JusticeU.S. Attorney’s OfficeNorthern District of Illinois FOR IMMEDIATE RELEASETuesday, April 11, 2023 CHICAGO — A suburban Chicago nurse has pleaded guilty in federal court to one count of tampering with a consumer product. SARAH DIAMOND, 30, of Woodstock was employed as the Assistant Director of Nursing at a Chicago-area medical rehabilitation center…
Meijer Recalls Select Premade Salads Due to Potential Health Risk
Summary Company Announcement Date: April 07, 2023 FDA Publish Date: April 10, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential Listeria monocytogenes contamination Company Name: Meijer Brand Name: Brand Name(s) Fresh From Meijer Product Description: Product Description Premade Salads Company Announcement GRAND RAPIDS, Mich., April 7, 2023 — Meijer, in…
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…
Fresh Express Incorporated Announces Precautionary Recall of Expired Fresh Salad Kits Due to Potential Health Risk
Summary Company Announcement Date: April 07, 2023 FDA Publish Date: April 07, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Listeria monocytogenes Company Name: Fresh Express Incorporated Brand Name: Brand Name(s) Fresh Express & Publix Product Description: Product Description Salad Kits Company Announcement Fresh Express Incorporated is voluntarily recalling a limited…
Revolution Farms, LLC Announces Expanded Recall of Lettuce Due to Possible Health Risk
Summary Company Announcement Date: April 06, 2023 FDA Publish Date: April 07, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Listeria monocytogenes Company Name: Revolution Farms Brand Name: Brand Name(s) Multiple brand names Product Description: Product Description Lettuce & Salad Kits Company Announcement Revolution Farms, LLC of Caledonia, Michigan is expanding…
Abbott Recalls the Readers used with the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash Glucose Monitoring Systems for Risk of Extreme Heat and Fire
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: FreeStyle Libre Flash Glucose Monitoring System, FreeStyle Libre 14 day Flash Glucose Monitoring System, FreeStyle Libre 2 Flash Glucose Monitoring System Product Models: all Reader…
Revolution Farms Announces the Voluntary Recall of Lettuce Because of Possible Health Risk
Summary Company Announcement Date: April 05, 2023 FDA Publish Date: April 05, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Listeria monocytogenes Company Name: Revolution Farms Brand Name: Brand Name(s) Multiple brand names Product Description: Product Description Lettuce & Salad Kits Company Announcement Revolution Farms of Caledonia, Michigan is voluntarily recalling…
FDA D.I.S.C.O. Burst Edition: FDA approval of Tafinlar (dabrafenib) with Mekinist (trametinib) for pediatric patients with low-grade glioma with a BRAF V600E 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 March 16, 2023, the FDA approved dabrafenib (brand name…