Summary Company Announcement Date: December 05, 2023 FDA Publish Date: December 04, 2023 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared Sesame seed, coconut, soy, wheat, milk, and egg Company Name: Lara’s Bakery 3, LLC. Brand Name: Brand Name(s) Lara’s Bakery 3 Product Description: Product Description Pan de Racho, Panque,…
Flour Is a Raw Food and Other Safety Facts
Image Español You may not realize it, but most flour is a raw food. And it hasn’t been treated to kill any bacteria (germs) it may contain. Cooking and baking is what kills any bacteria in flour, as well as in raw eggs that are often used with it. To stay safe, don’t eat or…
Allergy Alert for Undeclared Peanut in Maggi 2 Minute Noodles
Summary Company Announcement Date: December 01, 2023 FDA Publish Date: December 04, 2023 Product Type: Food & Beverages Allergens Reason for Announcement: Recall Reason Description Undeclared peanuts Company Name: Undeclared peanuts Brand Name: Brand Name(s) Product Description: Product Description 2 Minute Noodles Company Announcement New India Bazar, Milpitas, CA is recalling 2,400 packets of Maggi…
Antiseizure Medicines Keppra, Keppra XR, Elepsia XR, Spritam (levetiracetam) and Onfi, Sympazan (clobazam): Drug Safety Communication – FDA Warns of Rare but Serious Drug Reaction
[Posted 11/28/2023] AUDIENCE: Patient, Health Professional, Neurology, Dermatology, Allergy and Immunology, Pharmacy ISSUE: The FDA is warning that the antiseizure medicines, Keppra, Keppra XR, Elepsia XR, Spritam (levetiracetam) and Onfi, Sympazan (clobazam), can cause a rare but serious reaction that can be life-threatening if not diagnosed and treated quickly. This reaction is called Drug Reaction…
Florida Medical Clinic Owner and Pharmacy Technician Sentenced to Prison in Clinical Trial Fraud Scheme
Department of JusticeU.S. Attorney’s OfficeSouthern District of Florida FOR IMMEDIATE RELEASEThursday, November 30, 2023 A federal judge sentenced a medical clinic owner and a pharmacy technician for their involvement in a clinical trial fraud scheme that included the falsification and fabrication of clinical trial data, the Justice Department announced. Miguel Angel Montalvo Villa, 53, of…
BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies: FDA Safety Communication – FDA Investigating Serious Risk of T-cell Malignancy
[Posted 11/28/2023] TOPIC: BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies: FDA Safety Communication – FDA Investigating Serious Risk of T-cell Malignancy AUDIENCE: Patient, Health Professional, Risk Manager, Oncology, Pharmacy ISSUE: The FDA has received reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous…
Baxter Issues Urgent Medical Device Correction for Novum IQ Syringe Infusion Pump Due to Potential Impact of Downstream Occlusions on Infusion Volume
Summary Company Announcement Date: November 29, 2023 FDA Publish Date: November 30, 2023 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential for an incomplete infusion following one or more downstream occlusion alarms. Company Name: Baxter International, Inc. Brand Name: Brand Name(s) Product Description: Product Description Novum IQ syringe infusion pump. Company Announcement…
Manischewitz Issues a Product Mislabeling Advisory and Voluntary Recall on Some Very Limited Units of their Dark Chocolate Coins
Summary Company Announcement Date: December 01, 2023 FDA Publish Date: December 01, 2023 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared milk. Company Name: Manischewitz Brand Name: Brand Name(s) Manischewitz Product Description: Product Description Dark Chocolate Coins Company Announcement Bayonne, NJ. (December 1st , 2023) – Manischewitz, is recalling Manischewitz Dark…
Becton Dickinson (BD)/Carefusion 303 Recalls Alaris Infusion Pumps Due to Compatibility Issues with Cardinal Health Monoject Syringes
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: BD Alaris Syringe Module, BD Alaris PCU, and Alaris PCA Module Model Numbers: 8110, 8015, 8120 Distribution Dates: June 19, 2004 to September 22, 2023…
Cut Fruit Express Recalls “Fresh Cut Fruit Mix Containing Cantaloupe” Because of Possible Health Risk
Summary Company Announcement Date: November 30, 2023 FDA Publish Date: December 01, 2023 Product Type: Food & Beverages Fruit/Fruit Product Foodborne Illness Reason for Announcement: Recall Reason Description Potential to be contaminated with Salmonella Company Name: Cut Fruit Express, Inc. Brand Name: Brand Name(s) Multiple brands Product Description: Product Description Cantaloupe chunks and fruit mixes…