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: SD Biosensor STANDARD Q COVID-19 Ag Home Test Product Codes and Lot Numbers: See recall database entry Distribution Dates: August 26, 2021 to January 30,…
Celltrion USA Recalls Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive Test Results and Unauthorized Shelf Life
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: Celltrion DiaTrust COVID-19 Ag Rapid Test Product Code: 83QKP Lot Numbers: See Recall Database Entry Distribution Dates: June 2, 2021, to December 21, 2021 Devices…
LuSys Laboratories, Inc Recalls COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests Because They Are Not Authorized, Cleared, or Approved by the FDA
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: COVID-19 Antigen Test (Saliva) COVID-19 Antigen Test (Nasal) COVID-19 IgG/IgM Antibody Test Product Codes: Distribution Dates: June 1, 2020 to July 21, 2021 Devices Recalled…
Florida Dietary Supplement Salesman Sentenced for Conspiring to Defraud the FDA and Conspiring to Distribute Anabolic Steroids
U.S. Department of Justice FOR IMMEDIATE RELEASEFriday, March 11, 2022 A Florida man who led sales for a sports and dietary supplements retailer was sentenced today to 51 months in prison for conspiring to defraud the U.S. Food and Drug Administration (FDA) and conspiring to distribute anabolic steroids. According to court documents and evidence presented at…
Baxter recalls SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) due to the risk of not alarming for repeated upstream occlusion events
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 Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8) Product code: 35700BAX2 Spectrum IQ Infusion System with Dose IQ Safety Software (Version 9) Product Code:…
ACON Laboratories Issues a Recall of Non-EUA Authorized “Flowflex™ SARS-CoV-2 Antigen Rapid Test (Self-Testing)” Tests From the U.S. Market
Summary Company Announcement Date: January 09, 2022 FDA Publish Date: March 11, 2022 Product Type: Medical Devices Counterfeit Reason for Announcement: Recall Reason Description Unauthorized U.S. distribution-counterfeited product Company Name: ACON Laboratories, Inc. Brand Name: Brand Name(s) Flowflex™ Product Description: Product Description SARS-CoV-2 Antigen Rapid Test (Self-Testing) Company Announcement SAN DIEGO, CA, January 9, 2022…
Five Defendants Charged in Multi-Million Dollar Prescription Drug Smuggling & Money Laundering Scheme
Department of JusticeU.S. Attorney’s OfficeWestern District of Michigan FOR IMMEDIATE RELEASEFriday, March 11, 2022 GRAND RAPIDS, MICHIGAN – U.S. Attorney Andrew Birge announced that five defendants have been charged with conspiring to smuggle prescription drugs into the United States illegally. Brendon Gagne of Fountain, Colorado; James Funaro of Atlanta, Georgia; Jeremy Walenty of Tampa, Florida;…
Olympia Pharmacy Issues Voluntary Nationwide Recall of Seven Compounded Products Due to Being Out-of-Specification
Summary Company Announcement Date: March 10, 2022 FDA Publish Date: March 10, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Products are out of specification Company Name: Olympia Pharmacy Brand Name: Brand Name(s) Olympia Pharmaceuticals Product Description: Product Description Compounded Injectables Company Announcement Olympia Pharmacy is voluntarily recalling 11 specific lots of Trimix…
Fairmont Foods, Inc. Issues Recall of Spinach and Artichoke Dip Product Due to Misbranding and Undeclared Soy and Wheat Allergens
Summary Company Announcement Date: March 10, 2022 FDA Publish Date: March 10, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared soy and wheat Company Name: Fairmont Foods, Inc. Brand Name: Brand Name(s) Schwan’s Product Description: Product Description Spinach and Artichoke Dip Company Announcement Fairmont Foods, Inc. of Fairmont, MN is…
Albanese Confectionery Group, Inc. Recalls Dark Chocolate Espresso Bean 9 Oz. Tub Because of Undeclared Peanut Allergen
Summary Company Announcement Date: March 10, 2022 FDA Publish Date: March 10, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared peanuts Company Name: Albanese Confectionary Group, Inc. Brand Name: Brand Name(s) Product Description: Product Description Dark Chocolate Espresso Beans Company Announcement Albanese Confectionery Group, Inc. of Merrillville, Indiana is voluntarily…