Electrode Pad Correction: Megadyne Issues Correction for MEGA SOFT, MEGA SOFT DUAL and MEGA 2000 Patient Return Electrodes to Limit Risk of Pediatric Burns

UPDATES: Starting in September 2024, Megadyne communicated in a letter to new and existing customers reiterating the use of affected devices in patients aged 12 years and older. Additionally, Megadyne’s letter informs customers that the eIFU of devices indicates that no additional materials should be placed between the patient and Mega Soft pad (example: no…

Flagstone Foods, LLC. Allergy Alert on Undeclared Peanuts, Almonds and Pecan in Emerald Kettle Glazed Walnuts

Summary Company Announcement Date: August 16, 2024 FDA Publish Date: August 20, 2024 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared peanuts, almonds, pecans Company Name: Flagstone Foods, LLC Brand Name: Brand Name(s) Product Description: Product Description Emerald Kettle Glazed Walnuts Company Announcement FOR IMMEDIATE RELEASE – 16Aug 2024. –…

Compounding Device Inlet Correction: Baxter Healthcare Corporation Updates Use Instructions for Exactamix Automated Compounding Device Inlets due to Risk for Particulate Matter in Device Components

This recall involves updating instructions for using devices, and does not involve removing them 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 without following the updated instructions. Affected Product Product Names:…

Authentik Fudge Recalls Fudge with Nuts Because of Potential Mold Growth

Summary Company Announcement Date: August 21, 2024 FDA Publish Date: August 22, 2024 Product Type: Food & Beverages Foodborne Illness Reason for Announcement: Recall Reason Description Potential mold growth contamination Company Name: Authentik Fudge Brand Name: Brand Name(s) Montreal Fudge Product Description: Product Description Chocolate Fudge with Nuts Company Announcement Authentik Fudge of Sainte-Julie, Quebec,…

Gutierrez Distributor Recalls El Servidor Corp Ground Cinnamon Because of Possible Health Risk

Summary Company Announcement Date: August 19, 2024 FDA Publish Date: August 19, 2024 Product Type: Food & Beverages Spices, Flavors &  Salts Contaminants Reason for Announcement: Recall Reason Description Potentially contaminated with elevated levels of lead. Company Name: Gutierrez Distributor Brand Name: Brand Name(s) El Servidor Corp Product Description: Product Description Ground cinnamon Company Announcement Gutierrez…

Unilever U.S. Issues Allergy Alert on Undeclared Milk in Popsicle Jolly Rancher SingleServe Frozen Confection Pops

Summary Company Announcement Date: August 21, 2024 FDA Publish Date: August 21, 2024 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Unilever US Brand Name: Brand Name(s) Product Description: Product Description Jolly Rancher Green Apple, Blue Raspberry, Grape Frozen Confection Pop Company Announcement Only Popsicle Jolly Rancher…

Gutierrez Distributor Expands Recall of Ground Cinnamon Because of Possible Health Risk

Summary Company Announcement Date: August 23, 2024 FDA Publish Date: August 23, 2024 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Elevated lead Company Name: Gutierrez Distributors, LLC Brand Name: Brand Name(s) El Servidor Corp Product Description: Product Description Ground cinnamon Company Announcement A previous press release was issued 08/19/2024. This updated…

Asli Fine Foods . Recalls Asli Cinnamon Powder 7 oz Because of Possible Health Risk

Summary Company Announcement Date: August 29, 2024 FDA Publish Date: August 30, 2024 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Contains Lead Company Name: Asli Fine Foods Brand Name: Brand Name(s) Asli Fine Foods Product Description: Product Description Cinnamon powder Company Announcement Asli Fine Foods of Woodridge, IL is recalling Asli…

Sri Lakshmi Narasimhar Overseas LLC Issues an Allergy Alert on Undeclared Milk and Sesame Seeds in Bliss Tree Butter Snacks

Summary Company Announcement Date: August 23, 2024 FDA Publish Date: August 23, 2024 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared Allergen-Undeclared milk, sesame Company Name: Sri Lakshmi Narasimhar Overseas LLC Brand Name: Brand Name(s) Bliss Tree Product Description: Product Description Butter Snacks Company Announcement Sri Lakshmi Narasimhar Overseas LLC…

27 Individuals Indicted for Buying and Selling Wholesale Quantities of Misbranded and Diverted Prescription Drugs Resold to the Public Through Retail Pharmacies in Puerto Rico

Department of JusticeU.S. Attorney’s OfficeDistrict of Puerto Rico FOR IMMEDIATE RELEASEWednesday, September 25, 2024 HHS OIG and FDA are in charge of the investigation SAN JUAN, Puerto Rico – On September 19, 2024, a federal grand jury in the District of Puerto Rico returned an indictment charging 25 individuals with conspiracy to introduce misbranded drugs…