Summary Company Announcement Date: February 03, 2022 FDA Publish Date: February 03, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description potential to be contaminated with lead Company Name: EL CHAVITO, INC. Brand Name: Brand Name(s) El Chavito® Product Description: Product Description Saladitos Dried Salted Plums and Saladitos Enchilados Salted Plums With…
Ukoniq (umbralisib): Drug Safety Communication – FDA Investigating Possible Increased Risk of Death with Lymphoma
[Posted 02/03/2022] AUDIENCE: Oncology, Patient, Health Professional, Pharmacy ISSUE: The FDA is investigating a possible increased risk of death with the cancer medicine Ukoniq (umbralisib) approved to treat two specific types of lymphomas, which are cancers that affect the body’s immune system. The FDA determined that initial findings from a clinical trial evaluating Ukoniq to treat a related…
Prolific Fraudster Pleads Guilty
Department of JusticeU.S. Attorney’s OfficeDistrict of Puerto Rico FOR IMMEDIATE RELEASEWednesday, February 2, 2022 SAN JUAN, Puerto Rico – On January 27, 2022, Defendant Ramón Julbe-Rosa pleaded guilty before United States Magistrate Judge Marcos E. López to 12 counts including theft of government property, and introducing unapproved new drugs into the United States, announced W….
Horse Doping Drug Supplier Convicted in Manhattan Federal Court
Department of JusticeU.S. Attorney’s OfficeSouthern District of New York FOR IMMEDIATE RELEASEWednesday, February 2, 2022 Seth Fishman Peddled Hundreds of Customized Performance Enhancing Drugs to Racehorse Trainers Across the United States and Abroad Damian Williams, the United States Attorney for the Southern District of New York, announced the conviction at trial of defendant SETH FISHMAN,…
Esupplementsales, LLC Issues a Nationwide Recall of One Lot of Hard Dawn Due to the Presence of Undeclared Tadalafil
Summary Company Announcement Date: January 28, 2022 FDA Publish Date: January 31, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Undeclared Tadalafil Company Name: Esupplementsales, LLC Brand Name: Brand Name(s) Product Description: Product Description Hard Dawn Rise and Shine capsules Company Announcement FOR IMMEDIATE RELEASE – 01/28/2022 – Orangevale, CA, Esupplementsales, LLC is…
FDA D.I.S.C.O. Burst Edition: FDA approves Rylaze (asparaginase erwinia chrysanthemi (recombinant) – rywn) for treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase
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 have a quick update on another recent FDA cancer drug approval. On June 30, 2021, the FDA approved asparaginase erwinia chrysanthemi…
Ponte Vedra Man Convicted and Sentenced for Importing and Distributing Mislabeled Erectile Dysfunction Drug
Department of JusticeU.S. Attorney’s OfficeMiddle District of Florida FOR IMMEDIATE RELEASETuesday, February 1, 2022 Jacksonville, Florida – U.S. Magistrate Judge Patricia D. Barksdale has sentenced Timothy Terrance DeJoris (42, Ponte Vedra) to six months’ probation and a $2,500 fine for importing from China a mislabeled erectile dysfunction drug and distributing it online and in the…
Sturgis Nurse Charged with Tampering with Consumer Products
Department of JusticeU.S. Attorney’s OfficeWestern District of Michigan FOR IMMEDIATE RELEASETuesday, February 1, 2022 GRAND RAPIDS, MICHIGAN – Alison Marshall, 46, of Sturgis, Michigan, has been charged by a federal grand jury with tampering with a consumer product, United States Attorney Andrew Birge announced today. Special Agent in Charge Lynda Burdelik, from the Food and…
Philips Respironics CPAP, BiPAP, and Ventilator Recalls: Frequently Asked Questions
In June 2021, Philips Respironics voluntarily recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP), and continuous positive airway pressure (CPAP) machines due to potential health risks. The polyester-based polyurethane foam used in these medical devices to lessen sound and vibration can break down. If this occurs, black pieces…
FDA D.I.S.C.O. Burst Edition: FDA approvals of Brukinsa (zanubrutinib), for adult patients with relapsed or refractory marginal zone lymphoma, and Exkivity (mobocertinib) for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations
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 two recent FDA cancer drug approvals. On September 14, 2021, the FDA granted accelerated approval to…