Summary Company Announcement Date: December 15, 2022 FDA Publish Date: December 15, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Milk Company Name: THGH Partners LLC Brand Name: Brand Name(s) Power Life Product Description: Product Description High Impact Plant Protein Company Announcement Out of an abundance of caution, Power Life…
Something South African LLC Recalls the Peppercorn Collection Gift Set Because of Possible Health Risk
Summary Company Announcement Date: December 15, 2022 FDA Publish Date: December 15, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Mold (Aspergillus brasiliensis) and Ochratoxin A contamination Company Name: Something South African LLC Brand Name: Brand Name(s) World Market Product Description: Product Description Pepper Collection Gift Set Company Announcement Something South…
FDA D.I.S.C.O. Burst Edition: FDA approval of Adcetris (brentuximab vedotin) in combination with chemotherapy for pediatric patients with classical Hodgkin lymphoma
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 November 10, 2022, the FDA approved brentuximab vedotin brand…
Actualización de los sistemas endovasculares de injerto de AAA Endologix AFX y el riesgo de endofuga de tipo III: Comunicado de seguridad de la FDA
English Fecha de emisión: 6 de diciembre de 2022 La Administración de Alimentos y Medicamentos de los EE. UU. (FDA, por sus siglas en inglés) está actualizando nuestro comunicado de seguridad de enero de 2022 (en inglés) sobre el uso de los injertos endovasculares Endologix AFX utilizados para tratar a pacientes con aneurisma aórtico abdominal…
Former Director of Operations for New England Compounding Center Sentenced
Department of JusticeDistrict of Massachusetts FOR IMMEDIATE RELEASEWednesday, December 14, 2022 Final defendant sentenced in NECC case BOSTON – The former Director of Operations of the now-defunct New England Compounding Center (NECC) was sentenced yesterday in federal court in Boston for conspiring to defraud the Food and Drug Administration (FDA). In 2012, 753 patients in 20…
Utopia Foods Recalls “Enoki Mushrooms” Because of Possible Health Risk
Summary Company Announcement Date: December 13, 2022 FDA Publish Date: December 13, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Listeria monocytogenes contamination Company Name: Utopia Foods Inc Brand Name: Brand Name(s) Utopia Foods Inc Product Description: Product Description Enoki Mushrooms Company Announcement Utopia Foods Inc of Glendale, NY, is recalling…
Dunedin Woman Charged with Scheme to Distribute Unapproved New Drugs and Money Laundering
Department of JusticeMiddle District of Florida FOR IMMEDIATE RELEASEMonday, December 12, 2022 Tampa, Florida – United States Attorney Roger B. Handberg announces the return of an indictment charging Marina Sievert (57, Dunedin) with mail fraud, introduction into interstate commerce of an unapproved new drug, and monetary transactions in criminally derived property. If convicted, Sievert faces a…
Former Roswell Park Nurse Sentenced for Tampering with Medications Intended for Patients
Department of JusticeWestern District of New York FOR IMMEDIATE RELEASETuesday, December 13, 2022 BUFFALO, N.Y. — U.S. Attorney Trini E. Ross announced today that Kelsey A. Mulvey, 30, of Grand Island, NY, who was convicted of tampering with a consumer product, was sentenced to serve 37 months in prison by Chief U.S. District Judge Elizabeth A….
Voluntary Recall of Three Detect Covid-19 Test Lots
Summary Company Announcement Date: December 08, 2022 FDA Publish Date: December 12, 2022 Product Type: Medical Devices Laboratory Tests Reason for Announcement: Recall Reason Description There is an increased chance that the tests from the lot numbers listed below may give false negative results Company Name: Detect, Inc. Brand Name: Brand Name(s) Product Description: Product…
Thoroughbred Racehorse Trainer Jason Servis Pleads Guilty in Federal Doping Case
Department of JusticeSouthern District of New York FOR IMMEDIATE RELEASEFriday, December 9, 2022 Racehorse Trainer Jason Servis Acquired, Distributed, and Directed Others to Administer Prohibited Performance Enhancing Drugs to Racehorses Damian Williams, the United States Attorney for the Southern District of New York, announced that defendant JASON SERVIS pled guilty today for his role in the…