Summary Company Announcement Date: January 20, 2024 FDA Publish Date: January 20, 2024 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Sesame & Milk Company Name: Al Amir Fresh Foods Brand Name: Brand Name(s) Al Amir Fresh Foods Product Description: Product Description Hummus Dip & Tzatziki Cucumber Yogurt Company Announcement Al…
Prolia (denosumab): Drug Safety Communication – FDA Adds Boxed Warning for Increased Risk of Severe Hypocalcemia in Patients with Advanced Chronic Kidney Disease
[Posted 01/19/2024] AUDIENCE: Patient, Health Professional, Endocrinology, Nephrology, Pharmacy ISSUE: Based on a completed FDA review of available information, FDA has concluded that the osteoporosis medicine Prolia (denosumab) increases the risk of severe hypocalcemia, very low blood calcium levels, in patients with advanced chronic kidney disease (CKD), particularly patients on dialysis. Severe hypocalcemia appears to be more…
Certain ResMed Ltd Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices: FDA Safety Communication
Date Issued: January 18, 2024 The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers about AirFit and AirTouch mask models recalled by ResMed Ltd (ResMed). These masks are used with bilevel positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines and continuous positive airway pressure (CPAP)….
Whitley’s Peanut Factory Issues an Allergy Alert on Undeclared Peanuts, Milk, Soy, Wheat, and Sesame for Limited Units of Deluxe Nut Mix 12oz (340g)
Summary Company Announcement Date: January 18, 2024 FDA Publish Date: January 18, 2024 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Allergens – Peanuts, Milk, Soy, Wheat, and Sesame Company Name: Whitley’s Peanut Factory Brand Name: Brand Name(s) Whitley’s Peanut Factory Product Description: Product Description Deluxe Nut Mix Company Announcement Whitley’s…
Hans Kissle Issues Allergy Alert on Undeclared Soy & Egg in “Hans Kissle Mexican Style Quinoa Salad”
Summary Company Announcement Date: January 18, 2024 FDA Publish Date: January 18, 2024 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Allergens – Egg, Soy Company Name: Hans Kissle Brand Name: Brand Name(s) Product Description: Product Description Mexican Style Quinoa Salad Company Announcement Hans Kissle of Haverhill, MA, is recalling its…
Texas Company Pleads Guilty to Distributing Misbranded Dietary Supplements and Agrees to $4.5 Million Forfeiture
Department of JusticeU.S. Attorney’s OfficeWestern District of Texas FOR IMMEDIATE RELEASEFriday, January 12, 2024 Defyned Brands, an Austin, Texas, company also known as 5 Star Nutrition LLC, pleaded guilty today to a three-count information charging it with distributing misbranded dietary supplements. Pursuant to the plea agreement, the company admitted that from September 2018 to July 2020, it…
Pharmacist Sentenced for Illegally Dispensing Promethazine Cough Syrup and Earning Millions in Profits
Department of JusticeU.S. Attorney’s OfficeEastern District of Michigan FOR IMMEDIATE RELEASEFriday, January 12, 2024 Detroit, MI – Livonia pharmacy owner Zaman Alshafey was sentenced to three years in federal prison by United States District Court Judge Jonathan J.C. Grey following his guilty plea to wire fraud and money laundering. He was also ordered to forfeit…
Kinjin Food Pvt Ltd, Maharashtra, India Issues Allergy Alert on Undeclared Wheat Traces in “Vandevi Asafoeitida Yellow Powder”
Summary Company Announcement Date: January 10, 2024 FDA Publish Date: January 17, 2024 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description May contain undeclared wheat traces. Company Name: Kinjin Food Pvt. Ltd. Brand Name: Brand Name(s) Product Description: Product Description Asafoetida Yellow Powder in 50 gram, 100 gram, 200 gram, 500 gram,…
Big Island Candies Issues Allergen Alert on Undeclared Peanuts in “Makana Brownie Assortment”
Summary Company Announcement Date: January 16, 2024 FDA Publish Date: January 17, 2024 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Contains undeclared peanuts Company Name: Big Island Candies Brand Name: Brand Name(s) Big Island Candies Product Description: Product Description Brownie Assortment Company Announcement Big Island Candies of Hilo, Hawaii is voluntarily…
Brightfarms Recalls Spinach and Salad Kits Because of Possible Health Risk as a Result of Supplier Element Farms Recall
Summary Company Announcement Date: January 17, 2024 FDA Publish Date: January 17, 2024 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential Foodborne Illness-Listeria monocytogenes Company Name: BrightFarms Brand Name: Brand Name(s) BrightFarms Product Description: Product Description Spinach and Salad Kits Company Announcement Selinsgrove, PA (January 17, 2024) –– BrightFarms has issued…