U.S. Department of Justice FOR IMMEDIATE RELEASEMonday, April 24, 2023 A Georgia physician pleaded guilty today to charges related to the sale of a purported weight loss drug product that contained human chorionic gonadotropin, or HCG. Dr. Audrey Arona, 64, of Gainesville, Georgia, pleaded guilty to causing the introduction into interstate commerce of a misbranded…
NYC Mother and Son Charged with Interstate Shipment of Misbranded Animal Drugs
Department of JusticeU.S. Attorney’s OfficeEastern District of Pennsylvania FOR IMMEDIATE RELEASEWednesday, April 26, 2023 PHILADELPHIA – United States Jacqueline C. Romero announced that Bien King, 70, of Congers, NY and Khalil King, 36, of New York, NY were charged by indictment with conspiracy, distribution of unregistered and misbranded pesticides, and interstate shipment of misbranded animal…
FDA Warns of Use of Selective Androgen Receptor Modulators (SARMs) Among Teens, Young Adults
The U.S. Food and Drug Administration is warning consumers that the agency continues to receive adverse event reports related to selective androgen receptor modulators, commonly called SARMs. Social media posts by influencers and sellers of SARMs contribute to the availability and promotion of these dangerous products. Targeting teenagers and young adults, videos on social media…
American Outdoor Products Issues Allergy Alert on Undeclared Almonds in Backpacker’s Pantry Blueberry Peach Crisp
Summary Company Announcement Date: April 25, 2023 FDA Publish Date: April 25, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Product may contain undeclared almonds Company Name: American Outdoor Products Brand Name: Brand Name(s) Backpacker’s Pantry Product Description: Product Description Blueberry Peach Crisp Company Announcement American Outdoor Products of Boulder, CO…
Ellenos Real Greek LLC Issues Allergy Alert on Undeclared Egg In Vanilla Bean Yogurt 4oz Cup In Costco 12-Pack
Summary Company Announcement Date: April 25, 2023 FDA Publish Date: April 25, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Product may contain undeclared egg allergen Company Name: Ellenos Real Greek LLC Brand Name: Brand Name(s) Product Description: Product Description Greek Yogurt Company Announcement Ellenos Real Greek LLC of Federal Way,…
2023 Medical Device Recalls
Fresenius Kabi USA, LLC Recalls Ivenix Infusion System for Fluid Leak That May Delay or Interrupt Treatment 04/19/2023 Philips Respironics Recalls Certain Reworked DreamStation CPAP, BiPAP Machines for the Risk They May Deliver Inaccurate or Insufficient Therapy 04/07/2023 Abbott Recalls the Readers used with the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2…
Kawasho Foods USA Inc. Announces Expansion of Voluntary Recall of GEISHA Medium Shrimp 4oz. Due to Possible Under Processing
Summary Company Announcement Date: April 21, 2023 FDA Publish Date: April 22, 2023 Product Type: Food & Beverages Shellfish Foodborne Illness Reason for Announcement: Recall Reason Description Potential contamination with Clostridium botulinum Company Name: Kawasho Foods USA, Inc. Brand Name: Brand Name(s) Product Description: Product Description GEISHA Medium Shrimp, 4 oz can Company Announcement Kawasho…
Dakota Style Foods, Inc. Issues Expanded Allergy Alert on Undeclared Milk in Pretzels
Dakota Style 10oz Honey Mustard Pretzel Kravings D2212022 05/21/2023 Poly bag 84872-60031 Dakota Style 10oz Honey Mustard Pretzel Kravings D1332022 05/24/2023 Poly bag 84872-60031 Dakota Style 10oz Honey Mustard Pretzel Kravings D1462022 05/27/2023 Poly bag 84872-60031 Dakota Style 10oz Honey Mustard Pretzel Kravings D1382022 06/01/2023 Poly bag 84872-60031 Dakota Style 10oz Honey Mustard Pretzel Kravings…
Avanos Medical Inc Recalls Certain BALLARD ACCESS Closed Suction Systems for Neonates/Pediatrics for Risk of Inadequate Ventilation, Other Injuries from Cracked Manifolds
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: BALLARD ACCESS Closed Suction System for Neonates/Pediatrics with Y-Manifold; BALLARD ACCESS Closed Suction System for Neonates/Pediatrics with Elbow Manifold Product Stock Codes: Distribution Dates: October…
Massachusetts Health Care Company Agrees to Plead Guilty and Pay More Than $2.5 Million for Purchasing Botox That was Packaged and Labeled for Use Only in Foreign Countries
Department of JusticeU.S. Attorney’s OfficeDistrict of Massachusetts FOR IMMEDIATE RELEASEThursday, April 20, 2023 BOSTON – The United States Attorney’s Office announced today that Massachusetts-based medical corporation, Greater Boston Behavioral Health LLC, has agreed to plead guilty to charges related to the receipt of misbranded drugs and to pay in excess of $2.5 million in fines…