Department of JusticeU.S. Attorney’s OfficeEastern District of Michigan FOR IMMEDIATE RELEASEWednesday, October 6, 2021 BAY CITY – A Texas woman was sentenced today to six months in federal prison for introducing a misbranded drug into interstate commerce, announced Acting United States Attorney Saima Mohsin. Mohsin was joined in the announcement by Special Agent in Charge…
Urgent Bean and Soy Sprout Voluntary Recall
Summary Company Announcement Date: October 05, 2021 FDA Publish Date: October 07, 2021 Product Type: Food & Beverages Vegetable Products Foodborne Illness Reason for Announcement: Recall Reason Description Listeria monocytogenes Company Name: Fullei Fresh Brand Name: Brand Name(s) Fullei Fresh Product Description: Product Description Bean Sprouts and Soy Sprouts Company Announcement The purpose of this…
Simple Mills Issues Voluntary Recall on a Select Number of Lots of Fine Ground Sea Salt Almond Flour Crackers Due to the Presence of Undeclared Milk
Summary Company Announcement Date: October 06, 2021 FDA Publish Date: October 07, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Simple Mills Brand Name: Brand Name(s) Simple Mills Product Description: Product Description Fine Ground Sea Salt Almond Flour Crackers Company Announcement Simple Mills is initiating a voluntary…
UPDATE: Safe Use of Surgical Staplers and Staples – Letter to Health Care Providers
October 7, 2021 The U.S. Food and Drug Administration (FDA) is providing additional recommendations for health care providers to help protect patient safety and reduce the risk of adverse events associated with surgical staplers and staples for internal use. In addition, we are announcing new actions we are taking to help ensure the safe use…
Chocolate and the Chip LLC Issues Allergy Alert on Undeclared Allergens in Bakery Products
Summary Company Announcement Date: October 05, 2021 FDA Publish Date: October 06, 2021 Product Type: Food & Beverages Snack Food Item Allergens Reason for Announcement: Recall Reason Description Undeclared allergens (wheat, milk, soy, tree nuts) Company Name: Chocolate and the Chip Brand Name: Brand Name(s) Chocolate and the Chip Product Description: Product Description Bakery Products…
Imperative Care Inc. Recalls ZOOM 71 Reperfusion Catheter Due to Risk of Breaks During Use
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 ZOOM 71 Reperfusion Catheter Product Codes and Lot Numbers: See Recall Database Entry Devices Recalled in the United States: 3,098 Distribution Date: September 23, 2020 to August…
FDA D.I.S.C.O. Burst Edition: FDA approvals of Tivdak (tisotumab vedotin-tftv) for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy, and Jakafi (ruxolitinib) for chronic graft-versus-host disease after failure of one or two lines of systemic therapy
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 20, 2021, the FDA approved tisotumab vedotin-tftv (brand…
Medtronic Recalls Remote Controllers Used with Paradigm and 508 MiniMed Insulin Pumps for Potential Cybersecurity Risks
October 5, 2021 Update: Medtronic has expanded this recall of remote controllers used with either the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps due to potential cybersecurity risks. Medtronic sent updated instructions to people who use these devices, including instructions to stop using and return the remote controller. If you…
FDA D.I.S.C.O. Burst Edition: FDA approval of Cabometyx (cabozantinib) for locally advanced or metastatic differentiated thyroid cancer
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 another recent FDA cancer drug approval. On September 17, 2021, the FDA approved cabozantinib, brand name…
Greenhead Lobster Products Recalls Frozen Cooked Lobster Products Because of Possible Health Risk
Summary Company Announcement Date: October 02, 2021 FDA Publish Date: October 02, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential contamination with Listeria monocytogenes Company Name: Greenhead Lobster Products Brand Name: Brand Name(s) Product Description: Product Description Frozen cooked wild caught lobster meat Company Announcement Greenhead Lobster Products of Bucksport,…