Summary Company Announcement Date: December 11, 2022 FDA Publish Date: December 11, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential for cross-contamination with Cronobacter Akasaki Company Name: ByHeart Brand Name: Brand Name(s) Product Description: Product Description Whole Nutrition Infant Formula, Milk Based Powder with Iron for 0-12months Company Announcement None…
Remel, Inc Recalls Thermo Scientific Gram Negative IVD AST Sensititre Plate for risk of potential false susceptible results
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: Thermo Scientific Gram Negative IVD AST Sensititre Plate Catalog Number: GN2F, GN3F, GN4F, GN6F, GN7F, HPB1, ESB1F, CMC5VGNF, CMC7AFLF, MDRGN3F, STP6F, STP7F Lot Numbers: See…
Dewei Medical Equipment Co. Recalls DNA/RNA Preservation Kits That Are Not Authorized, Cleared, or Approved by the FDA
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: Dewei Medical Equipment Co. DNA/RNA Preservation Kits Product Catalog Number: DW-80005-1B Distribution Dates: May 2020 to January 2022 Devices Recalled in the U.S.: 250,000 Date…
Theranos President Sentenced to More Than 12 Years for Fraud That Jeopardized Patient Health And Bilked Investors of Millions
Department of JusticeNorthern District of California FOR IMMEDIATE RELEASEWednesday, December 7, 2022 SAN JOSE – Ramesh “Sunny” Balwani was sentenced today to 155 months (12 years, 11 months) in federal prison for fraud that risked patient health by misrepresenting the accuracy of Theranos blood analysis technology and that defrauded Theranos investors of millions of dollars, announced…
Northern Food I/E Recalls “Sweetened Jujube” Due to Undeclared Sulfites
Summary Company Announcement Date: December 06, 2022 FDA Publish Date: December 07, 2022 Product Type: Food & Beverages Fruit/Fruit Product Allergens Reason for Announcement: Recall Reason Description Undeclared Sulfites Company Name: Northern Food I/E Inc. Brand Name: Brand Name(s) Product Description: Product Description Sweetened Jujube Company Announcement “When a Government Agency Partner announces a company’s…
Florida Company Sentenced to $2.5 Million Fine for Unlawful Distribution of Anabolic Steroids
Department of JusticeEastern District of Kentucky FOR IMMEDIATE RELEASEWednesday, December 7, 2022 FRANFORT, Ky. — A Florida company, Modern Therapy, LLC, was sentenced on Friday to pay a $2.5 million fine by U.S. District Judge Gregory VanTatenhove for the unlawful distribution of anabolic steroids. Modern Therapy operated out of Hallandale Beach, Florida. According to its plea…
LIDL Voluntarily Recalls 8.4 Oz Favorina Branded Advent Calendar (Premium Chocolate with a Creamy Filling) Due to Potential Salmonella Contamination
Summary Company Announcement Date: December 06, 2022 FDA Publish Date: December 06, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential presence of Salmonella Company Name: Lidl US Brand Name: Brand Name(s) Product Description: Product Description Advent Calendar (Premium Chocolate with a Creamy Filling) Company Announcement ARLINGTON, VA –Lidl US has…
FDA D.I.S.C.O. Burst Edition: FDA approval of Imjudo (tremelimumab) in combination with Imfinzi (durvalumab) and platinum-based chemotherapy for metastatic 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 another quick update on a recent FDA cancer drug approval. On November 10, 2022, the FDA approved tremelimumab (brand name…
Update on Endologix AFX Endovascular AAA Graft Systems and Risk of Type III Endoleak: FDA Safety Communication
Date Issued: December 6, 2022 The U.S. Food and Drug Administration (FDA) is updating our January 2022 safety communication on the use of Endologix AFX endovascular grafts used to treat patients with abdominal aortic aneurysm (AAA). On December 6, 2022, the FDA approved new labeling for the currently available product, the AFX2 Endovascular AAA System…
Former Malden Firefighter Sentenced for Distributing Controlled Substances
Department of JusticeDistrict of Massachusetts FOR IMMEDIATE RELEASETuesday, December 6, 2022 BOSTON – A former Malden firefighter was sentenced yesterday in federal court in Boston for conspiring to distribute controlled substances including oxycodone, suboxone, Klonopin and Adderall. Joshua Eisnor, 43, of North Reading, was sentenced by U.S. District Court Judge Leo T. Sorokin to five years…