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…
Risks with Exactech Equinoxe Shoulder System with Defective Packaging – FDA Safety Communication
314-01-02 GLENOID,KEELED, CEMENTED,Mates with 38, 41, 44 head, alpha curvature, Small 10885862084408 314-01-03 GLENOID,KEELED, CEMENTED,Mates with 38, 41, 44 head, alpha curvature, Medium 10885862084415 314-01-04 GLENOID,KEELED, CEMENTED,Mates with 38, 41, 44 head, alpha curvature, Large 10885862084422 314-01-12 GLENOID,KEELED, CEMENTED,Mates with 47, 50, 53 head, beta curvature, Small 10885862084439 314-01-13 GLENOID,KEELED, CEMENTED,Mates with 47, 50, 53…
ROi CPS, LLC Recalls Regard Operative Lap P&S Surgical Kit Due to Possible Lack of Sterility
Please be aware, this recall is a correction, not a product removal. 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: Regard Operative Lap P&S Surgical Kit Product Codes: LRO – See Recall Database…
Govvi WOW! contains hidden ingredient
[12-21-2023] The Food and Drug Administration is advising consumers not to purchase or use Govvi WOW!, a product promoted and sold for weight loss on various websites, including www.ebay.com and possibly in some retail stores. FDA laboratory analysis confirmed that Govvi WOW! contains undeclared 1,4-dimethylamylamine (DMAA). The dietary supplement industry often refers to DMAA as…
Busse Hospital Disposables, Inc. Recalls Care Trays and Kits Containing Sterile Water Based Products Under Recall by Nurse Assist
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: Tracheostomy Care Kit, Dressing Change Kit, and Tracheostomy Care Set Product Codes: NXA, MCY – See Recall Database Entry: Model Numbers: Catalog No. 800 TRACHEOSTOMY…
Fresenius Kabi USA, LLC Recalls Ivenix Large Volume Pump (LVP) of the Ivenix Infusion System Due to Mechanical Interference
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: Ivenix Large Volume Pump Product Codes: FRN Model Numbers: LVP-0004 Distribution Dates: October 1, 2021 to July 31, 2023 Devices Recalled in the U.S.: 938…