Summary Company Announcement Date: October 08, 2024 FDA Publish Date: October 16, 2024 Product Type: Drugs Reason for Announcement: Recall Reason Description Device & Drug Safety – Unapproved Drug Company Name: C&A Naturistics Brand Name: Brand Name(s) Product Description: Product Description AK Forte Dietary Supplement Company Announcement FOR IMMEDIATE RELEASE – 10/8/24 – National City,…
Reser’s Fine Foods Announces Voluntary Recall of Limited Number of Meal Kits Due to Recalled Chicken from Ingredient Supplier (BrucePac)
Summary Company Announcement Date: October 10, 2024 FDA Publish Date: October 11, 2024 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential Listeria monocytogenes contamination Company Name: Reser’s Fine Foods Brand Name: Brand Name(s) Bistro 28, Don Pancho Product Description: Product Description Meal kits containing chicken Company Announcement Beaverton, OR…
Enoki King Mushroom Farm Recalls Enoki Because of Possible Health Risk
Summary Company Announcement Date: October 11, 2024 FDA Publish Date: October 11, 2024 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential Listeria monocytogenes contamination Company Name: Enoki King Mushroom Farm Brand Name: Brand Name(s) Enoki King Product Description: Product Description Enoki Mushroom 5.3 oz Company Announcement FOR IMMEDIATE RELEASE…
Tipical Latin Food, Corp. Issues Allergy Alert on Undeclared Wheat in Cachapa de Maiz
Summary Company Announcement Date: October 11, 2024 FDA Publish Date: October 11, 2024 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Potential or Undeclared Allergen – Wheat Company Name: Tipical Latin Food Corp. Brand Name: Brand Name(s) Los Andes Foods Product Description: Product Description Cachapa de Maiz sweet corn pancakes Company…
Wismettac Asian Foods Issues Allergy Alert on Undeclared Sesame in Seasoned Seaweed
Summary Company Announcement Date: October 10, 2024 FDA Publish Date: October 11, 2024 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential or Undeclared Allergen – Sesame Company Name: Wismettac Asian Foods, Inc. Brand Name: Brand Name(s) Product Description: Product Description Korean Seasoned Seaweed Company Announcement Wismettac Asian Foods, Inc., Santa Fe…
$2,125,640 Recouped in Civil Settlements for Violations of the False Claims Act from Local Pharmacies in Cidra and Florida, Puerto Rico
Department of JusticeU.S. Attorney’s OfficeDistrict of Puerto Rico FOR IMMEDIATE RELEASEWednesday, September 25, 2024 SAN JUAN, Puerto Rico – The United States Attorney’s Office reached two settlement agreements with local pharmacies and their respective owners to resolve allegations that they violated the False Claims Act by submitting or causing to be submitted fraudulent claims for payment…
Infusion Pump Recall: Zyno Medical Removes Z-800, Z-800F, Z-800W, and Z800WF Infusion Pumps due to an Air-in-Line Software Defect That May Allow Larger than Expected Air Bubbles to Enter Patients
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Pump Model Unique Device Identifier (UDI-DI) Software Revision Z-800 00814377102006 6.1.01 and 6.1.07z Z-800W 00814371020020…
Magellan Diagnostics Sentenced for Concealing Malfunction in Lead Testing Devices
Department of JusticeU.S. Attorney’s OfficeDistrict of Massachusetts FOR IMMEDIATE RELEASEThursday, October 10, 2024 Company failed to notify FDA about serious malfunction in lead testing devices that resulted in inaccurately low blood level results in children and adults BOSTON –Magellan Diagnostics, Inc., a medical device company headquartered in Billerica, Mass., was sentenced yesterday in federal court…
FDA Adds Warning About Rare Occurrence of Serious Liver Injury with Use of Veozah (fezolinetant) for Hot Flashes Due to Menopause. Stop Medicine if Signs and Symptoms of Liver Injury Occur – Drug Safety Communication
[Posted 9/12/2024] AUDIENCE: Patient, Health Professional, OBGYN, Endocrinology ISSUE: The FDA is warning that Veozah (fezolinetant), a medicine used to treat hot flashes due to menopause, can cause rare but serious liver injury. If there are signs and symptoms suggesting liver injury, stopping the medicine could prevent worsening liver injury and potentially return liver function to normal….
Infusion Pump Administration Set Recall: Fresenius Kabi USA Removes Certain Ivenix Large Volume Pump Primary Administration Sets
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. Affected Product Product Names: Ivenix LVP Primary Administration Sets Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25) Unique…