Summary Company Announcement Date: June 07, 2023 FDA Publish Date: June 08, 2023 Product Type: Food & Beverages Snack Food Item Allergens Reason for Announcement: Recall Reason Description Undeclared peanuts. Company Name: Regal Health Food International, Inc. Brand Name: Brand Name(s) Regal Gourmet Snacks Product Description: Product Description Milk Chocolate Raisins Company Announcement Regal Health…
FDA D.I.S.C.O. Burst Edition: FDA approval of Polivy (polatuzumab vedotin-piiq) for previously untreated diffuse large B-cell lymphoma, not otherwise specified, and high-grade B-cell lymphoma
Podcast Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on a recent FDA cancer drug approval. On April 19, 2023, the FDA approved polatuzumab vedotin-piiq, brand…
Abiomed Recalls Specific Impella 5.5 with SmartAssist for Purge Fluid Leaks that Can Cause Pump Stop and Loss of Support
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: Impella 5.5 with SmartAssist Product Code: 0550-0008 Product Serial Numbers: See Recall Database Entry Distribution Dates: September 28, 2021 to March 6, 2023 Devices Recalled…
Virginia Man Pleads Guilty to Introducing Misbranded Drugs into Interstate Commerce
Department of JusticeU.S. Attorney’s OfficeMiddle District of Florida FOR IMMEDIATE RELEASEMonday, June 5, 2023 Jacksonville, Florida –United States Attorney Roger B. Handberg announces that Jonathan Corbett Cosie (54, Chesterfield, VA) has pleaded guilty to two counts of introducing a misbranded drug into interstate commerce with the intent to defraud or mislead. Cosie faces a maximum…
Colorado Man Sentenced for Conspiring to Distribute Tramadol
Department of JusticeU.S. Attorney’s OfficeDistrict of Vermont FOR IMMEDIATE RELEASEMonday, June 5, 2023 Burlington, Vermont – The United States Attorney’s Office stated that John Gentile, 59, of Arvada, Colorado, was sentenced by United States District Court Judge William K. Sessions III to two years of probation for conspiring to distribute Tramadol. Tramadol is an opioid…
Food Wholesaler Pleads Guilty to Smuggling Tainted Chinese Eel
Department of JusticeU.S. Attorney’s OfficeCentral District of California FOR IMMEDIATE RELEASEMonday, June 5, 2023 LOS ANGELES – A Pomona man and his food wholesale company have pleaded guilty in federal court to attempting to smuggle Chinese frozen roasted eel for human consumption which had been previously refused entry into the United States, federal authorities announced…
Non-sterile, Single-use Pneumatic Tourniquet Cuffs Conservation Strategies – Letter to Health Care Providers
June 5, 2023 The U.S. Food and Drug Administration (FDA) is aware of health care facilities and providers experiencing localized supply constraints of non-sterile, single-use pneumatic tourniquet cuffs in the United States. These devices are mainly used in elective limb surgeries and in emergency and trauma settings. During interruption in the supply of these devices,…
Retired New Jersey Doctor Sentenced for Selling Toxic DNP Online and Faking Cancer Diagnosis to Avoid Trial
Department of JusticeU.S. Attorney’s OfficeEastern District of Pennsylvania FOR IMMEDIATE RELEASEThursday, June 1, 2023 PHILADELPHIA – United States Attorney Jacqueline C. Romero announced that William Merlino, 85, of Mays Landing, NJ, was sentenced to thirty-three months in prison and one year of supervised release by United States District Court Judge Gerald A. McHugh for selling…
Don’t Use Products Marketed to Treat Molluscum, a Common Skin Condition
Image Español If you’re bothered by bumps on your skin, don’t try to diagnose yourself or treat your condition with products that haven’t been approved by the U.S. Food and Drug Administration. Instead, visit a health care professional for a proper diagnosis and to make a treatment plan. One common condition that some people try…
Tillamook Issues Allergy Alert on Undeclared Wheat and Soy in Tillamook Waffle Cone Swirl Ice Cream Packaged in Chocolate Peanut Butter Ice Cream Carton
Summary Company Announcement Date: May 31, 2023 FDA Publish Date: May 31, 2023 Product Type: Food & Beverages Ice Cream/Frozen Dairy Allergens Reason for Announcement: Recall Reason Description Undeclared wheat and soy Company Name: Tillamook County Creamery Association Brand Name: Brand Name(s) Tillamook Waffle Cone Swirl Ice Cream Product Description: Product Description Company Announcement May…