Summary Company Announcement Date: December 01, 2021 FDA Publish Date: December 01, 2021 Product Type: Animal & VeterinaryFood & Beverages Reason for Announcement: Recall Reason Description Pseudomonas aeruginosa Company Name: Liva Global, Inc. Brand Name: Brand Name(s) LivaOne and BioLifePet Product Description: Product Description Probiotics Company Announcement VISALIA, CA December 1, 2021 – Livia Global,…
UPDATE: Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics’ Precice Devices – Letter to Health Care Providers
December 1, 2021 The U.S. Food and Drug Administration (FDA) continues to monitor potential biocompatibility concerns associated with NuVasive Specialized Orthopedics’ Precice devices made from stainless steel and titanium. Today, the FDA is providing updated information and recommendations on the titanium-based Precice devices. On November 30, 2021, NuVasive issued a field safety notice to inform…
International Golden Foods, Inc (IGF) Recalls Tahini Because of Possible Health Risk
Summary Company Announcement Date: November 30, 2021 FDA Publish Date: November 30, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Salmonella Company Name: International Golden Foods, Inc. Brand Name: Brand Name(s) Al Kanater Product Description: Product Description Company Announcement International Golden Foods, Inc (IGF) of Bensenville, IL is voluntarily recalling certain…
Teleflex Incorporated Announces Worldwide Recall of Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR
Summary Company Announcement Date: November 26, 2021 FDA Publish Date: November 30, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Inner lumen may detach from the device’s basket Company Name: Teleflex Incorporated Brand Name: Brand Name(s) Product Description: Product Description Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR Company Announcement WAYNE, Pa.,…
How Sweet It Is: All About Sugar Substitutes
Image Español Whether it’s to cut down on the number of calories they consume or any of a variety of other reasons, some people use sugar substitutes – also called high-intensity sweeteners – to sweeten and add flavor to their foods. They can be used alone to sweeten foods and beverages such as iced tea…
French National Charged with Making False Statements to FDA to Fraudulently Obtain Control of Pharmaceutical Product
Department of JusticeU.S. Attorney’s OfficeDistrict of New Jersey FOR IMMEDIATE RELEASEWednesday, November 24, 2021 NEWARK, N.J. – A French national will make his initial appearance today for his role in an attempt to fraudulently gain control of the rights to sell a weight-loss drug in the United States, Acting U.S. Attorney Rachael A. Honig announced….
Calise & Sons Bakery, Inc. Recalls Golden Flax Scala Bread Because of Possible Health Risk
Summary Company Announcement Date: November 24, 2021 FDA Publish Date: November 29, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared sesame seeds Company Name: Calise Bakery Brand Name: Brand Name(s) Calise Bakery Product Description: Product Description Golden Flax Seed Scala Bread Company Announcement Press Release – Product Recall 11/24/21Item: Golden…
FDA D.I.S.C.O. Burst Edition: FDA approval of Keytruda (pembrolizumab) for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions
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 17, 2021, the FDA approved pembrolizumab (brand name…
Florida Corporation and Executives Plead Guilty to Conspiracy to Sell Anabolic Steroids and Unlawful Dietary Supplements
U.S. Department of Justice FOR IMMEDIATE RELEASEFriday, November 19, 2021 Blackstone Labs LLC (“Blackstone”) and two of its executives pleaded guilty to conspiring to sell illegal anabolic steroids and other unlawful products marketed as dietary supplements, the Justice Department announced. According to court documents, Phillip “PJ” Braun, 40, of Boca Raton, Florida, and Aaron Singerman,…
Nine Indicted in Counterfeit Promethazine-Codeine Drug Trafficking Conspiracy
Department of JusticeU.S. Attorney’s OfficeEastern District of Texas FOR IMMEDIATE RELEASEFriday, November 12, 2021 BEAUMONT, Texas – A federal grand jury in Beaumont has returned a three-count indictment charging nine individuals in drug trafficking conspiracy in the Eastern District of Texas, announced Acting U.S. Attorney Nicholas J. Ganjei today. The indictment was returned on Nov….