Africa Imports Issues Voluntary Recall of Organic Moringa Leaf Powder Due to Potential Salmonella Contamination
Summary Company Announcement Date: November 06, 2025 FDA Publish Date: November 06, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential to be contaminated with Salmonella Company Name: Africa Imports Brand Name:...FDA approves daratumumab and hyaluronidase-fihj for high-risk smolderi
On November 6, 2025, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech, Inc.) for adults with high-risk smoldering multiple myeloma (SMM).Full prescribing information for Darzalex Faspro will be posted on...CYFENDUS
STN: 125761Proper Name: Anthrax Vaccine Adsorbed, AdjuvantedTradename: CYFENDUSManufacturer: Emergent BioDefense Operations Lansing LLC.Indication:CYFENDUS (Anthrax Vaccine Adsorbed, Adjuvanted) is a vaccine indicated for post-exposure prophylaxis of disease following...Blue Oven Bakery, Inc. Issues a Voluntary Recall Due to Undeclared Milk Allergens in Their English Muffin
Summary Company Announcement Date: October 31, 2025 FDA Publish Date: November 06, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Undeclared milk Company Name: Blue Oven Bakery, Inc. Brand Name: Product Description:...BioThrax Lead Page
STN: BL 103821Proper Name: Anthrax Vaccine AdsorbedTradename: BioThraxManufacturer: Emergent BioDefense Operations Lansing LLCIndications:BioThrax is a vaccine indicated for the active immunization for the prevention of disease caused by Bacillus anthracis in persons...African Food on Wheels Inc. Recalls Oven Dried Fish (Scomberomorus Cavalla) Because of Possible Health Risk
Summary Company Announcement Date: November 05, 2025 FDA Publish Date: November 06, 2025 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description Potential to be contaminated with Clostridium botulinum Company Name: African Food on Wheels...How to Prepare a Pre-Request for Designation (Pre-RFD)
Docket Number: FDA-2017-D-0040 Issued by: Guidance Issuing Office Office of the Commissioner, Office of the Chief Medical Officer, Office of Combination Products This guidance is intended to assist sponsors in obtaining a preliminary assessment from the U.S. Food and...AceCosm – 718610 – 11/03/2025
Recipient: AceCosm Hong Kong SAR China Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTERNovember 3, 2025AceCosm:This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed your...Click To Verify Security & Validation
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