UPDATE: On September 18, 2024, Zimmer Biomet sent a follow-up letter to U.S. surgeons that included the FDA’s recommendations from this safety communication, a plain language communication that surgeons can share with patients, and plans for the CPT Hip System Femoral Stem to be exited in the U.S. Date Issued: September 17, 2024 The U.S….
Sunco & Frenchie Issues an Allergy Alert on Undeclared Sulfites in Golden Raisins
Summary Company Announcement Date: August 26, 2024 FDA Publish Date: August 26, 2024 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared Allergen-Undeclared Sulfites Company Name: Sunco & Frenchie LLC Brand Name: Brand Name(s) Product Description: Product Description Golden Raisins Company Announcement Sunco & Frenchie LLC of Pine Brook, New Jersey…
M&P Food Production Issues Allergy Alert on Undeclared Wheat and Milk in Vareniki, Pirozhki, and Blintzes
Summary Company Announcement Date: August 29, 2024 FDA Publish Date: August 29, 2024 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared wheat and milk Company Name: M&P Food Productio. Ltd. Brand Name: Brand Name(s) M&P Food Productio. Ltd. Product Description: Product Description Blintzes, pirozhki, and vareniki Company Announcement M&P Food…
Niitakaya USA Inc. Issues Allergy Alert on Undeclared Allergen of Fish (Bonito) in #3700 Shiso Katsuo Ninniku/#3701 Miso Katsuo Ninniku
Summary Company Announcement Date: September 04, 2024 FDA Publish Date: September 05, 2024 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared Fish (Bonito) Company Name: Niitakaya USA Inc. Brand Name: Brand Name(s) Product Description: Product Description Shiso Katsuo Ninniku & Miso Katsuo Ninniku Company Announcement Niitakaya USA Inc. of Montebello,…
Milo’s Poultry Farms, LLC., Recalls Eggs Because of Possible Health Risk
Summary Company Announcement Date: September 06, 2024 FDA Publish Date: September 06, 2024 Product Type: Food & Beverages Egg/Egg Product Foodborne Illness Reason for Announcement: Recall Reason Description Potential to be contaminated with Salmonella Company Name: Milo’s Poultry Farms, LLC Brand Name: Brand Name(s) Milo’s Poultry Farms & Tony’s Fresh Market Product Description: Product Description…
Hammond’s Candies Issues Allergy Alert on Undeclared Milk in Hammond’s Dark Chocolate Filled Mini Waffle Cones
Summary Company Announcement Date: September 05, 2024 FDA Publish Date: September 06, 2024 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared Milk Company Name: Hammond’s Candies Brand Name: Brand Name(s) Hammond’s Product Description: Product Description Dark Chocolate Filled Mini Waffle Cones Company Announcement Hammond’s Candies of Denver, CO is recalling…
Innovation Bakers, LLC Issues Allergy Alert on Undeclared Walnut in 7-Eleven Fudge Brownie Distributed in Southern California
Summary Company Announcement Date: September 10, 2024 FDA Publish Date: September 11, 2024 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared walnuts Company Name: Innovation Bakers, LLC Brand Name: Brand Name(s) Product Description: Product Description Fudge Brownie Company Announcement Innovation Bakers, LLC of Fullerton, CA, is issuing a voluntary limited…
Magellan Diagnostics Pleads Guilty to Criminal FDCA Charges
Department of JusticeU.S. Attorney’s OfficeDistrict of Massachusetts FOR IMMEDIATE RELEASEThursday, June 27, 2024 BOSTON – Magellan Diagnostics, Inc., a medical device company headquartered in Billerica, Mass., pleaded guilty today in federal court in Boston to criminal charges relating to its concealment of a device malfunction that produced inaccurately low lead test results for tens of…
Former New York Cheese Producer Sentenced for Selling Raw Milk Cheese Products Linked to Listeria Outbreak
Department of JusticeU.S. Attorney’s OfficeNorthern District of New York FOR IMMEDIATE RELEASETuesday, July 9, 2024 SYRACUSE, NEW YORK – Johannes Vulto, age 64, a former raw milk cheese manufacturer, and Vulto Creamery LLC, the company Vulto founded and owned, were each sentenced today in federal court in Syracuse after each previously pleading guilty to one…
U.S. Compounding, Inc. Pleads Guilty To Multiple Fraud Offenses And Company Vice President Indicted In Scheme To Distribute Drugs Nationally Using False Prescriptions
Department of JusticeU.S. Attorney’s OfficeSouthern District of New York FOR IMMEDIATE RELEASETuesday, July 9, 2024 U.S. Compounding, Inc., a Subsidiary of a Publicly Traded Company, Pled Guilty to Mail Fraud and Food, Drug, and Cosmetic Act Offense Damian Williams, the United States Attorney for the Southern District of New York, and Christie M. Curtis, the…