FDA 101: Regulating Biological Products

Biological products often represent the cutting edge of medical science and research. Also known as biologics, these products replicate natural substances such as enzymes, antibodies, or hormones in our bodies. Biological products can be composed of sugars, proteins, or nucleic acids, or a combination of these substances. They may also be living entities, such as…

Animal Health International Inc. Pleads Guilty to Introduction of Misbranded Drugs into Interstate Commerce

Department of JusticeU.S. Attorney’s OfficeWestern District of Virginia FOR IMMEDIATE RELEASEFriday, February 14, 2020 Animal Health International Will Pay More Than $52 Million in Forfeitures, Fines, and Penalties Abingdon, VIRGINIA – Animal Health International Inc. (AHI), a Colorado corporation that obtains prescription drugs for animals from manufacturers for further distribution to veterinarians, farms, feedlots, and other facilities,…

Dark Web Fentanyl Trafficker Known as “The Drug Llama” Sentenced To 13 Years In Federal Prison

Department of JusticeU.S. Attorney’s OfficeSouthern District of Illinois FOR IMMEDIATE RELEASEWednesday, February 12, 2020 Melissa Scanlan (a/k/a “The Drug Llama”) has been sentenced to 160 months in federal prison in the United States District Court for the Southern District of Illinois for trafficking fentanyl throughout the United States via the “dark web,” engaging in an international money…

FDA and Partners Working to Prevent Surgical Fires

The Food and Drug Administration (FDA) is building a coalition of public and private healthcare organizations to prevent a medical error—the surgical fire. A surgical fire is a fire that occurs in, on or around a patient undergoing a medical or surgical procedure.  An estimated 550 to 650 surgical fires happen every year in U.S….

Gourmet International and Butlers Chocolates Issue Allergy Alert on Undeclared Milk in Butlers Irish Whiskey Dark Chocolate 3.5 oz Tablet Bar

Summary Company Announcement Date: February 13, 2020 FDA Publish Date: February 13, 2020 Product Type: Food & BeveragesChocolate/Cocoa ProductAllergens Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Gourmet International and Butlers Chocolates UC Brand Name: Brand Name(s) Product Description: Product Description Irish Whiskey Dark Chocolate Bar Company Announcement Gourmet International and Butlers Chocolates UC                                …

Save A Lot Issues Allergy Alert on Undeclared Peanuts in Coburn Farms 4.5oz Sharp Yellow Cheddar Cheese, Cherry Juice-Infused Dried Cranberries & Roasted Sea Salted Cashews Snackers

Summary Company Announcement Date: February 13, 2020 FDA Publish Date: February 13, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared peanut Company Name: Save A Lot Brand Name: Brand Name(s) Coburn Farms Product Description: Product Description Coburn Farms 4.5oz Sharp Yellow Cheddar Cheese, Cherry Juice-Infused Dried Cranberries & Roasted Sea…

Belviq, Belviq XR (lorcaserin) by Eisai: Drug Safety Communication – FDA Requests Withdrawal of Weight-Loss Drug

[Posted 02/13/2020] AUDIENCE: Patient, Health Professional, Pharmacy ISSUE: FDA has requested that the manufacturer of Belviq, Belviq XR (lorcaserin) voluntarily withdraw the weight-loss drug from the U.S. market because a safety clinical trial shows an increased occurrence of cancer. The drug manufacturer, Eisai Inc,. has submitted a request to voluntarily withdraw the drug.  When FDA approved lorcaserin…

Medtronic Recalls MiniMed Insulin Pumps for Incorrect Insulin Dosing

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 MiniMed 600 Series Insulin Pumps Model 630G (MMT-1715) – all lots before October 2019 Model 670G (MMT-1780) – all lots before August 2019 Distribution Dates: Model 630G…

Lotte Int’l America Corp Issues Allergy Alert on Undeclared Almonds in Chocopies

Summary Company Announcement Date: February 11, 2020 FDA Publish Date: February 12, 2020 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared almonds Company Name: Lotte Int’l America Corp. Brand Name: Brand Name(s) Product Description: Product Description Chocopie (original, banana, and cacao) Company Announcement Lotte Int’l America Corp is recalling its 11.85-ounce…

Voluntary Recall Notice of Sunny Select Au Jus Gravy Mix 1 oz Pouches Due to Unlabeled Dairy Allergen

Summary Company Announcement Date: February 11, 2020 FDA Publish Date: February 12, 2020 Product Type: Food & BeveragesGravy/SaucesAllergens Reason for Announcement: Recall Reason Description Undeclared milk allergen Company Name: McCormick and Company, Inc. Brand Name: Brand Name(s) Sunny Select Product Description: Product Description Au Jus Gravy Mix Company Announcement McCormick & Company, Inc. is initiating…