artnaturals® Issues Voluntary Recall of Limited Batches of 8oz Bottles of Scent Free Hand Sanitizer Due to Presence of Impurities

Summary Company Announcement Date: October 26, 2021 FDA Publish Date: October 27, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Presence of Impurities Company Name: artnaturals Brand Name: Brand Name(s) artnaturals Product Description: Product Description Scent Free Hand Sanitizer Company Announcement artnaturals is voluntarily recalling ten manufacturing lots of artnaturals 8oz…

Windstone Medical Packaging dba Aligned Medical Solutions Issues Nationwide Recall of Cardinal Health’s Monoject™ Flush Prefilled Saline Syringes Placed Into the Following Kits; AMS-9041CP Leaderflex Insertion Kit With Ultrasound, AMS-9046CP-1 Insertion Tray-RX, AMS8939A Universal Procedure Pack w/S

Summary Company Announcement Date: October 20, 2021 FDA Publish Date: October 27, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential for the plunger to draw back after the air has been expelled and reintroduced air back into the syringe Company Name: Windstone Medical Packaging dba Aligned Medical Solutions Brand Name: Brand…

Bobo’s Issues a Voluntary Allergy Alert on Undeclared Peanuts in Almond Butter Bars

Summary Company Announcement Date: October 27, 2021 FDA Publish Date: October 27, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Contain undeclared peanuts Company Name: Bobo’s Brand Name: Brand Name(s) Product Description: Product Description Almond butter bars Company Announcement Bobo’s of Boulder, Colorado is issuing a voluntary recall of Bobo’s 4-Pack…

Potandon Produce Voluntarily Recalls Select White and Yellow Whole Onions Because of Possible Health Risk

Summary Company Announcement Date: October 26, 2021 FDA Publish Date: October 26, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential Salmonella contamination Company Name: Potandon Produce LLC Brand Name: Brand Name(s) Green Giant Product Description: Product Description Yellow and white onions Company Announcement Potandon Produce L.L.C. of Idaho Falls, Idaho…

FDA D.I.S.C.O. Burst Edition: FDA approval of Tecentriq (atezolizumab) for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non-small cell lung cancer

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 October 15, 2021, the FDA approved atezolizumab (brand name…

International Law Enforcement Operation Targeting Opioid Traffickers on the Darknet Results in 150 Arrests Worldwide and the Seizure of Weapons, Drugs, and over $31 Million

U.S. Department of Justice FOR IMMEDIATE RELEASETuesday, October 26, 2021 Darknet Narcotics Vendors Selling to Tens of Thousands of U.S. Residents Charged Today, the Department of Justice, through the Joint Criminal Opioid and Darknet Enforcement (JCODE) team joined Europol to announce the results of Operation Dark HunTor, a coordinated international effort on three continents to disrupt…

Study Coordinator Pleads Guilty in Scheme to Falsify Clinical Drug Trial Data

U.S. Department of Justice FOR IMMEDIATE RELEASETuesday, October 26, 2021 WASHINGTON – A Colorado man pleaded guilty today in connection with his participation in a scheme to falsify clinical drug trial data.   Duniel Tejeda, 35, of Canon City, Colorado and formerly of Miami, Florida, pleaded guilty before U.S. District Judge Robert N. Scola Jr. of…

Cedar’s Mediterranean Foods Issues Allergy Alert on Undeclared Pine Nut in 10 Oz. Organic Mediterranean Hommus

Summary Company Announcement Date: October 25, 2021 FDA Publish Date: October 25, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared pine nut Company Name: Cedar’s Mediterranean Foods Brand Name: Brand Name(s) Product Description: Product Description Organic Mediterranean Hommus Company Announcement Cedar’s Mediterranean Foods, of Ward Hill, MA is voluntarily recalling…

FDA D.I.S.C.O. Burst Edition: FDA approvals of Verzenio (abemaciclib) for adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer, & Keytruda (pembrolizumab) for persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1)

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 two recent FDA cancer drug approvals. On October 12, 2021, the FDA approved abemaciclib (brand name…