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 another recent FDA cancer drug approval. On July 26, 2021, the FDA approved pembrolizumab (brand name…
Federal Jury Finds Former Nurse Guilty of Fraudulently Obtaining and Tampering with Opioid Pain Killer
Department of JusticeU.S. Attorney’s OfficeDistrict of Utah FOR IMMEDIATE RELEASEFriday, July 23, 2021 SALT LAKE CITY- Nathan Pehrson, 41, of Sandy, was convicted by a federal jury in the District of Utah of three counts related to fraudulently obtaining and tampering with the pain killing narcotic hydromorphone, a powerful schedule II opioid drug that is used…
Ballreich Snack Food Company Recalls Bar-B-Q Seasoned Potato Chips Because of Possible Health Risk
Summary Company Announcement Date: August 10, 2021 FDA Publish Date: August 10, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Salmonella Company Name: Ballreich Snack Food Co. Brand Name: Brand Name(s) Ballreich’s Product Description: Product Description BAR-B-Q Potato Chips Company Announcement Ballreich Snack Food Co. Tiffin, Ohio, is recalling its 1.5oz,…
Frito-Lay Issues Limited Voluntary Recall on Undeclared Milk in Wavy Lay’s Original Potato Chips Distributed in North Carolina, South Carolina and Virginia
Summary Company Announcement Date: August 11, 2021 FDA Publish Date: August 11, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Frito-Lay Brand Name: Brand Name(s) Product Description: Product Description Wavy Lay’s Original Potato Chips Company Announcement Frito-Lay today issued a voluntary recall of a limited number –…
SterRx, LLC Issues Voluntary Nationwide Recall of Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL Due to Microbial Contamination
Summary Company Announcement Date: August 10, 2021 FDA Publish Date: August 10, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to waterborne microbial contamination Company Name: SterRx, LLC Brand Name: Brand Name(s) SterRx, LLC Product Description: Product Description Sodium Bicarbonate in 5% Dextrose Injection 150mEq per 1,000 mL Company Announcement SterRx, LLC…
Able Groupe Recalling Products Labeled as Infant Formula Formulas Have Insufficient Iron Levels as Per Requirements for Infant Formula in The U.S., and Products Do Not Meet Other FDA Requirements
Summary Company Announcement Date: August 08, 2021 FDA Publish Date: August 08, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Products do not meet FDA requirements. Company Name: Able Groupe Brand Name: Brand Name(s) HiPP Holle Bioland Kendamil Product Description: Product Description Products labeled as infant formula Company Announcement Able Groupe…
Boston Scientific Recalls INGENIO Family of Pacemakers and CRT-Ps Due to Risk of Incorrect Transition to Safety Mode
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 Names: INGENIO Family of Pacemakers and CRT-Ps (includes models ADVANTIO DR EL, INGENIO DR EL and VITALIO DR EL) Product Codes: LWP Model Numbers: J174, J177,…
Eight Medical International Recalls Recirculator 8.0 Disposable Lavage Kits due to Potential Exposure to High Levels of Aluminum
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 Recirculator 8.0 Disposable Lavage Kit Product Code: 8100 Lot Numbers: 20021361, 20202106, 20202106, 20018480, 19854186, 20019438, 20018480, 19854186, 19854185, 20202106, 20019438, 19854184, 20202106, 20018480, 20202106, 20018480, 18687686…
DSD Merchandisers, Inc. Issues Allergy Alert on Undeclared Peanuts in Dark Chocolate Malt Balls 9oz Tub
Summary Company Announcement Date: August 04, 2021 FDA Publish Date: August 04, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared peanuts Company Name: DSD Merchandisers, Inc. Brand Name: Brand Name(s) DSD Merchandisers Product Description: Product Description Dark Chocolate Malt Balls Company Announcement DSD Merchandisers, Inc. of Livermore, CA is recalling…
Eco-Med Pharmaceutical Issues Voluntary Recall of Eco-Gel 200
Summary Company Announcement Date: August 04, 2021 FDA Publish Date: August 04, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Product is contaminated with bacteria (Burkholderia cepacia complex) Company Name: Eco-Med Pharmaceutical Brand Name: Brand Name(s) Multiple brand names Product Description: Product Description Ultrasound Gel Company Announcement Etobicoke, Ontario (August 4, 2021)…