Summary Company Announcement Date: December 04, 2021 FDA Publish Date: December 07, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Process issues that could lead to a lack of sterility assurance for products intended to be sterile and could impact the safety and quality of non-sterile products Company Name: Edge Pharma, LLC Brand…
Beware of Vaping Products with Unproven Health Claims
Image CaptionColourful overlapping silhouettes of e-cigarettes or vapers The U.S. Food and Drug Administration wants consumers to know certain “wellness” vaping products containing vitamins and/or essential oils are being illegally sold with unproven claims and could be harmful if used. Currently, no vaping products are approved by the FDA to prevent or treat any health…
Nurse Pleads Guilty to Tampering with Morphine at Moses Lake Clinic
Department of JusticeU.S. Attorney’s OfficeEastern District of Washington FOR IMMEDIATE RELEASETuesday, December 7, 2021 Spokane, Washington – Esther Rae Tuller, age 40, of Moses Lake, Washington, has pleaded guilty to tampering with morphine medication while working as a registered nurse. Chief United States District Judge Stanley A. Bastian accepted Tuller’s guilty plea and scheduled a…
Federal Jury Convicts Pharmacy Owner for Role in $174 Million Telemedicine Pharmacy Fraud Scheme
U.S. Department of Justice FOR IMMEDIATE RELEASEFriday, December 3, 2021 On Dec. 2, a federal jury in Greeneville, Tennessee, convicted Peter Bolos, 44, of Tampa, Florida, of 22 counts of mail fraud, conspiracy to commit health care fraud and introduction of a misbranded drug into interstate commerce, following a month-long trial. According to court documents…
Dakota Toms Issues Allergy Alert on Undeclared Egg and Milk in Chicken Salad Croissant
Summary Company Announcement Date: December 07, 2021 FDA Publish Date: December 07, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared egg and milk Company Name: Dakota Toms Brand Name: Brand Name(s) Dakota Toms Product Description: Product Description Chicken Salad Croissant Company Announcement Dakota Toms of Corsica, SD is recalling Chicken…
Beware of Illegally Marketed Diabetes Treatments
Sound Too Good To Be True? Then it’s probably a scam. Watch out for these and similar red flags: “Lowers your blood sugar naturally!” “Inexpensive therapy to fight and eliminate type II diabetes!” “Protects your eyes, kidneys, and blood vessels from damage!” “Replaces your diabetes medicine!” “Effective treatment to relieve all symptoms of diabetes!” “Natural…
Gilead Issues A Voluntary Nationwide Recall of Two Lots of Veklury® (Remdesivir) Due to Presence of Glass Particulates
Summary Company Announcement Date: December 03, 2021 FDA Publish Date: December 03, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Presence of glass particulates Company Name: Gilead Sciences Inc. Brand Name: Brand Name(s) Product Description: Product Description Veklury® (remdesivir 100 mg for injection) Company Announcement Foster City, CA, Gilead Sciences Inc. (Nasdaq: GILD)…
FDA D.I.S.C.O. Burst Edition: FDA approval of Fyarro (sirolimus protein-bound particles for injectable suspension (albumin-bound)) for locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor
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 November 22, 2021, the FDA approved sirolimus protein-bound particles…
Colorado Nurse Sentenced to Federal Prison for Taking Controlled Substances from Patients
Department of JusticeU.S. Attorney’s OfficeDistrict of Colorado FOR IMMEDIATE RELEASEWednesday, December 1, 2021 DENVER – Alicia Nickel-Tangeman, age 44, formerly of Woodland Park, Colorado, was sentenced to 12 months in federal prison for obtaining controlled substances using fraud and deception while she was on the job as a Registered Nurse at a hospital in Colorado….
Bottled Water Everywhere: Keeping it Safe
Español Seems like almost everyone is carrying a bottle of water these days. The U.S. Food and Drug Administration (FDA) regulates bottled water products, working to ensure that they’re safe to drink. FDA protects consumers of bottled water through the Federal Food, Drug, and Cosmetic Act (FD&C Act), which makes manufacturers responsible for producing safe,…