Summary Company Announcement Date: May 26, 2023 FDA Publish Date: May 25, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Allergen Company Name: A.S.K. Foods, Inc. Brand Name: Brand Name(s) Product Description: Product Description Penne Rigate Mozzarella Salad Company Announcement A.S.K. Foods, Inc. of Palmyra, PA is voluntarily recalling select…
FDA Updating Warnings to Improve Safe Use of Prescription Stimulants Used to Treat ADHD and Other Conditions.
[Posted 05/26/2023] AUDIENCE: Patient, Health Professional, Pharmacy, Psychiatry, Pediatrics ISSUE: The FDA is requiring updates to the Boxed Warning and other information to ensure the prescribing information is made consistent across the entire class of these medicines. The current prescribing information for some prescription stimulants does not provide up to date warnings about the harms of…
Drugs
Delivery Method: VIA UPS and Electronic Mail Product: Tobacco Recipient: Recipient Name Steve Green Recipient Title Owner Drive Thru Vapors, LLC d/b/a Drive Thru Vapors Dallas 4216 LBJ FreewayDallas, TX 75244United States [email protected] Issuing Office: Center for Tobacco Products United States WARNING LETTER May 18, 2023 Dear Mr. Green: The Center for Tobacco Products of…
Pennsylvania Physician Sentenced to Prison for HOPE Clinic Prescription Practices
Department of JusticeU.S. Attorney’s OfficeSouthern District of West Virginia FOR IMMEDIATE RELEASEThursday, May 25, 2023 CHARLESTON, W.Va. – Brian Gullett, D.O., 46, of Clarksville, Pennsylvania, was sentenced today to six months in prison, to be followed by one year of supervised release, and fined $5,000 for aiding and abetting obtaining a controlled substance by fraud….
T.W. Garner Food Company Issues Voluntary Recall on Texas Pete® Buffalo Wing Sauce Due to Undeclared Soy
Summary Company Announcement Date: May 25, 2023 FDA Publish Date: May 25, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared Soy Company Name: T.W. Garner Food Company Brand Name: Brand Name(s) Texas Pete Product Description: Product Description Buffalo Wing Sauce Company Announcement T.W. Garner Food Company is voluntarily recalling 50,688…
SD BioSensor, Inc. Recalls Certain Pilot COVID-19 At-Home Tests for Potential Bacteria Contamination
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: Pilot COVID-19 At-Home Tests Product Codes: See Safety Communication Distribution Dates: August 2022 to March 2023 Devices Recalled in the U.S.: 2,712,767 U.S. Government:…
Flowers Foods Issues Voluntary Recall on Tastykake Chocolate Kandy Kakes Due to Undeclared Peanuts
Summary Company Announcement Date: May 24, 2023 FDA Publish Date: May 24, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared peanuts Company Name: Flowers Foods Brand Name: Brand Name(s) Product Description: Product Description Chocolate Kandy Kakes Company Announcement Flowers Foods, Inc. (NYSE: FLO) is voluntarily recalling certain Tastykake® Chocolate Kandy…
FDA D.I.S.C.O. Burst Edition: FDA approval of Omisirge (omidubicel-onlv) to reduce time to neutrophil recovery and infection in patients with hematologic malignancies
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 therapeutic approval. On April 17, 2023, the FDA approved omidubicel-onlv, brand name…
Draeger Medical Recalls Seattle PAP Plus and Breathing Circuit/Anesthesia Kits for Risk of Loose or Detached Components That Can Restrict Breathing Support
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: Seattle PAP Plus, VentStar Basic (P)180, VentStar Basic(P)250, VentStar Watertrap (P) 180, VentStar Watertrap (P) 180 w/oLL, VentStar Anesthesia WT (P)180, VentStar breathing bag Set…
Van Leeuwen Issues Voluntary Recall on Undeclared Walnuts in its Brown Sugar Chunk Ice Cream Pints
Summary Company Announcement Date: May 23, 2023 FDA Publish Date: May 23, 2023 Product Type: Food & Beverages Ice Cream/Frozen Dairy Allergens Reason for Announcement: Recall Reason Description Undeclared walnuts Company Name: Van Leeuwen Ice Cream LLC Brand Name: Brand Name(s) Van Leeuwen Product Description: Product Description BROWN SUGAR CHUNK WITH COOKIE DOUGH & BROWNIES…