Image CaptionFDA scientists conducting blood research. Español Every two seconds in the U.S., someone needs a blood transfusion or blood product—people of all ages who are injured, need surgery or who are suffering from illness. The Food and Drug Administration’s (FDA) primary responsibility with regard to blood and blood products is to assure the safety…
2022 Safety Communications
The FDA posts Medical Device Safety Communications to describe the FDA’s current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management. 2022 Safety Communications Content current as of: 01/13/2022 Regulated Product(s) Article source: http://www.fda.gov/medical-devices/safety-communications/2022-safety-communications
Avances para salvar vidas con sangre
Image CaptionCientíficos de la FDA que realizan investigaciones sobre la sangre. English Cada dos segundos en los Estados Unidos, alguien necesita una transfusión de sangre o un producto sanguíneo — son personas de todas las edades que sufren una lesión, necesitan cirugía o que sufren de alguna enfermedad. La responsabilidad primordial de la Administración de…
Lohxa LLC Issues Voluntary Nationwide Recall of Senna Syrup 8.8mg/5mL Due to Microbial Contamination
Summary Company Announcement Date: January 11, 2022 FDA Publish Date: January 12, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential microbial contamination Company Name: Lohxa LLC Brand Name: Brand Name(s) Product Description: Product Description Senna Syrup 5mL Company Announcement FOR IMMEDIATE RELEASE – 01/11/2022 – Worcester, MA. Lohxa LLC is voluntarily recalling…
FDA D.I.S.C.O. Burst Edition: FDA approvals of Trodelvy (sacituzumab govitecan) for locally advanced/metastatic urothelial cancer who received platinum-containing chemotherapy & either PD-1/PD-L1 inhibitor and Opdivo (nivolumab) in combination with chemotherapy for metastatic gastric cancer and esophageal adenocarcinoma
Podcast Welcome 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 have another update on two recent FDA cancer drug approvals. On April 13, 2021, the FDA granted accelerated approval to sacituzumab govitecan…
Stop Using LuSys Laboratories COVID-19 Tests: FDA Safety Communication
Date Issued: January 11, 2022 The U.S. Food and Drug Administration (FDA) is warning people to stop using the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and the LuSys Laboratories COVID-19 IgG/IgM Antibody Test. The performance of these tests has not been adequately established and the FDA believes there is likely a high risk of false…
FDA: Foods Must Contain What Label Says
Image Español As someone who cares about what your family eats, you make it a practice when shopping to read the labels on food packages. And you have the right to expect that the information on the label, including the ingredient list, is accurate. The good news is that the Food and Drug Administration (FDA)…
Animal Cloning and Food Safety
Image After years of detailed study and analysis, the Food and Drug Administration has concluded that meat and milk from clones of cattle, swine (pigs), and goats, and the offspring of clones from any species traditionally consumed as food, are as safe to eat as food from conventionally bred animals. This conclusion stems from an…
Cardiovascular Systems, Inc Recalls WIRION Embolic Protection Device Due to Complaints of Filter Breakage During Retrieval
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 (Include the following information) Product Names: WIRION Embolic Protection Device Product Codes: See Recall Database Entry Model Numbers: All products and lots Manufacturing Dates: January 3, 2021…
Injectable Skin Lightening and Skin Bleaching Products May Be Unsafe
Image Espanol Consumers need to beware of products to lighten or whiten their complexion. These products, which include both injectable skin whitening and skin bleaching products, are potentially unsafe and ineffective, and might contain unknown harmful ingredients or contaminants. Injectable skin whitening products are marketed for injection into a vein or muscle or under the…