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 therapeutic approval. On April 17, 2023, the FDA approved omidubicel-onlv, brand name…
Draeger Medical Recalls Seattle PAP Plus and Breathing Circuit/Anesthesia Kits for Risk of Loose or Detached Components That Can Restrict Breathing Support
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 Names: Seattle PAP Plus, VentStar Basic (P)180, VentStar Basic(P)250, VentStar Watertrap (P) 180, VentStar Watertrap (P) 180 w/oLL, VentStar Anesthesia WT (P)180, VentStar breathing bag Set…
Van Leeuwen Issues Voluntary Recall on Undeclared Walnuts in its Brown Sugar Chunk Ice Cream Pints
Summary Company Announcement Date: May 23, 2023 FDA Publish Date: May 23, 2023 Product Type: Food & Beverages Ice Cream/Frozen Dairy Allergens Reason for Announcement: Recall Reason Description Undeclared walnuts Company Name: Van Leeuwen Ice Cream LLC Brand Name: Brand Name(s) Van Leeuwen Product Description: Product Description BROWN SUGAR CHUNK WITH COOKIE DOUGH & BROWNIES…
Meijer Issues Allergy Alert on Undeclared Milk in Frederik’s Dark Chocolate Almonds and Meijer Express Go Cup Dark Chocolate
Summary Company Announcement Date: May 23, 2023 FDA Publish Date: May 23, 2023 Product Type: Food & Beverages Snack Food Item Allergens Reason for Announcement: Recall Reason Description Undeclared Milk Company Name: Meijer Brand Name: Brand Name(s) Meijer Express, Frederik’s by Meijer Product Description: Product Description Dark Chocolate Almonds Company Announcement GRAND RAPIDS, Mich., May…
Grand Rapids Physician Pays Over $135,000 For Allegedly Using Foreign, Unapproved Botox to Treat Medicare Beneficiaries
Department of JusticeU.S. Attorney’s OfficeWestern District of Michigan FOR IMMEDIATE RELEASETuesday, May 23, 2023 GRAND RAPIDS – U.S. Attorney for the Western District of Michigan Mark Totten today announced that Derek Lado, D.O., and his Grand Rapids practice, Elite Medical Spine & Musculoskeletal Center PLLC (Elite), have agreed to pay $135,871.84 to resolve allegations that…
Nurse Who Stole Painkillers, Replacing Them with Saline and Putting Surgical Patients at Risk, Sentenced to Four Years
Department of JusticeU.S. Attorney’s OfficeEastern District of North Carolina FOR IMMEDIATE RELEASEMonday, May 22, 2023 RALEIGH, N.C. – A former Fuquay-Varina nurse was sentenced today to 48 months in prison and three years of supervised release for tampering with painkillers intended for surgery patients. On March 9, 2022, Melissa Elizabeth Chacona pled guilty to the…
DIBE LLC Issues Allergy Alert on Undeclared Soy, Walnuts, and Wheat in “Tetas Mireya Sabor Nutella, Toddy, Ferrero, Galleta Maria & Galleta Oreo”
Summary Company Announcement Date: May 22, 2023 FDA Publish Date: May 22, 2023 Product Type: Food & Beverages Snack Food Item Allergens Reason for Announcement: Recall Reason Description Undeclared Soy, Walnuts, and Wheat Company Name: DIBE LLC Brand Name: Brand Name(s) TETAS MIREYA Product Description: Product Description TETAS MIREYA SABOR NUTELLA, TODDY, FERRERO, GALLETA MARIA…
ICU Medical Recalls Replacement Batteries for Plum 360, Plum A+, and Plum A+3 Infusion Systems Due to Diminished Battery Life that May Impact Infusion Delivery
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: Replacement Batteries for Plum 360, Plum A+, and Plum A+3 Infusion Systems Battery List Numbers: Plum 360: SUB0000864 Plum A+ and Plum A+3: SUB0000594 Devices…
Novis PR LLC Emite Retiro Voluntario de Gotas Pediátricas G-Supress DX Debido a Empaque Incorrecto
Summary Company Announcement Date: May 18, 2023 FDA Publish Date: May 19, 2023 Product Type: Drugs Over-the-Counter Drugs Reason for Announcement: Recall Reason Description Packaging may contain incorrect product Company Name: NOVIS PR LLC Brand Name: Brand Name(s) G-SUPRESS DX Product Description: Product Description Cough Suppressant, expectorant, nasal decongestant pediatric drops Company Announcement 15/05/23– San…
Novis PR LLC Issues Voluntary Recall of G-Supress DX Pediatric Drops Due to Incorrect Packaging
Summary Company Announcement Date: May 18, 2023 FDA Publish Date: May 19, 2023 Product Type: Drugs Over-the-Counter Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety/Mislabeling Company Name: NOVIS PR LLC Brand Name: Brand Name(s) G-SUPRESS DX Product Description: Product Description Cough Suppressant, expectorant, nasal decongestant pediatric drops Company Announcement 05/15/23– San Juan,…