The FDA approved Ctexli (chenodiol) for the treatment of cerebrotendinous xanthomatosis (CTX) in adults. Ctexli is the first FDA-approved drug to treat CTX, a very rare lipid storage disease.
KEDAKE, INC. of Houston, TX is recalling it’s 2 lb packages of Las Ollas Botana Mix Snacks because they may contain undeclared Sesame, Soy, Wheat, Yellow No 5, Yellow No 6, and Red No 6. People who have an allergy or severe sensitivity...
The FDA works to ensure the safety of millions of units of blood and blood components donated in the U.S. each year. Learn how the FDA helps safeguard the blood supply and how you can donate blood.
Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 03/22/2019 Short Title (70 char) CMC Enterprise Pharmacy. Charlotte, NC. 483 issued 03/22/2019 FEI Number 3014539004 Firm Name CMC Enterprise...
Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 04/04/2019 Short Title (70 char) Triangle Compounding Pharmacy Inc. Cary, NC. 483 issued 04/04/2019 FEI Number 3004969894 Firm Name Triangle...
This is the Guidance for Industry - Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
This is the Draft Guidance for Industry - Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
This is the Draft Guidance for Industry - Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA)....
ZB Importing LLC is voluntarily recalling certain lots of six varieties of Ulker Brand snack rolls, biscuits, and wafers due to undeclared wheat, egg and/or milk in the Ingredient List and/or Contains Statement on the product labels....
Naturipe Value Added Fresh LLC. of Alma, GA, is recalling its 2.1 oz./60 gram packages of "Berry Buddies, Berries & Pancakes" bento box snack packs because they contain wheat and EGGS that were not declared on the label. People who...
Mauna Loa Macadamia Nut Company LLC of Kea’au, HI is voluntarily recalling one batch of its Mauna Loa Milk Chocolate Covered Macadamias snack (1oz) pouches, due to the presence of undeclared almonds which are an allergen.
BD (Becton, Dickinson and Company) today announced the voluntary recall of one lot of ChloraPrep™ Clear 1 mL Applicators due to fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides
This is the main page for the CBER Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) November 21, 2024 announcement and meeting materials.
FDA approved the first rapid-acting biosimilar insulin product, Merilog (insulin-aspart-szij), a biosimilar to its reference product Novolog (insulin aspart), to improve glycemic control in adults and children with diabetes mellitus.
Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 11/15/2024 Short Title (70 char) Exela Pharma Sciences LLC. Lenoir, NC. 483 issued 11/15/2024 FEI Number 3008563008 Firm Name Exela Pharma Sciences...
Is It Really "FDA Approved"? Maybe you’ve seen these words on a company’s website or in a commercial promoting a product or treatment. Here are some facts about products that are, and aren’t, FDA approved.
Clinical trials give us important information about the safety and effectiveness of a treatment. Before deciding whether your child should join a clinical trial, learn as much as you can, including the risks and benefits.
ICU Medical, Inc. is voluntarily recalling one lot each of POTASSIUM CHLORIDE Inj. bags with overwrap labels 10mEq, packaged in cases of POTASSIUM CHLORIDE Inj. 20 mEq, to the user level. ICU medical has received a customer complaint...
JE Bakery 2019, LLC, Minneapolis MN is voluntarily recalling its Raisin Bran Muffin 6 count due to a labeling error. The affected product was mislabeled and instead contains Glorious Morning Muffins, which contains Walnuts, a known...
Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 09/30/2024 Short Title (70 char) Pine Pharmaceuticals, LLC. Tonawanda, NY. 483 issued 09/30/2024 FEI Number 3010943533 Firm Name Pine...
Task Description Request Please post to the OII FOIA Electronic Reading Room Record Date 10/22/2024 Short Title (70 char) Boothwyn Pharmacy LLC. Kennett Square, PA. 483 issued 10/22/2024 FEI Number 1000076625 Firm Name Boothwyn Pharmacy...
AKT Trading Inc of Torrance, California is recalling 120 packages of Menma Ajitsuke Prepared Bamboo Shoot Product, because it has the potential to be contaminated with Clostridium botulinum, a bacterium which can cause life-threatening...
Jack and the Green Sprouts, Inc. of River Falls, WI is recalling 5oz packages of Alfalfa sprouts that expired on 1/29/25 because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious...