[Posted 01/12/2022] AUDIENCE: Dentistry, Anesthesiology, Patient, Health Professional, Pharmacy ISSUE: The FDA is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth. The dental problems, including tooth decay, cavities, oral infections, and loss of teeth, can be serious and have been reported even in patients with no history of…
Lily’s Sweets Voluntarily Recalls Lily’s Peppermint Flavor Baking Chips Due to Undeclared Presence of Soy Lecithin
Summary Company Announcement Date: January 14, 2022 FDA Publish Date: January 14, 2022 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description May contain undeclared soy lecithin Company Name: Lily’s Sweets Brand Name: Brand Name(s) Product Description: Product Description Peppermint Flavor Baking Chips Company Announcement Lily’s Sweets, is voluntarily recalling 18,855 cases of…
Advances in Saving Lives with Blood
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
Suburban Chicago Nurse Charged with Tampering with Morphine Prescribed to Patients
Department of JusticeU.S. Attorney’s OfficeNorthern District of Illinois FOR IMMEDIATE RELEASEThursday, January 13, 2022 CHICAGO — A suburban Chicago nurse removed morphine from bottles prescribed to two patients and replaced it with another liquid, knowing the diluted substance would be dispensed to the patients, according to a federal indictment returned in U.S. District Court in…
Pharmacy Manager Indicted for Tampering with a Consumer Product and Obtaining Opiates by Fraud
Department of JusticeU.S. Attorney’s OfficeDistrict of Vermont FOR IMMEDIATE RELEASEThursday, January 13, 2022 The Office of the United States Attorney for the District of Vermont stated that Brian Thomas Badgley, 37, of Waterbury, Vermont appeared yesterday in United States District Court in Burlington for an arraignment on a two-count indictment charging him with tampering with…
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…
Florida Co-Owner of Clinical Trial Company Pleads Guilty to Obstructing FDA Inspection
U.S. Department of Justice FOR IMMEDIATE RELEASEWednesday, January 12, 2022 A Florida woman pleaded guilty today to obstructing a 2017 regulatory inspection in connection with an alleged scheme to fraudulently falsify clinical drug trial data. According to court documents, Olga Torres, 49, of Miami, co-owned a clinical research site called Unlimited Medical Research. Unlimited Medical Research…