FDA Roundup: January 14, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Original source: http://www.fda.gov/news-events/press-announcements/fda-roundup-january-14-2022

FDA Approves Novel Treatment to Control Pain in Cats with Osteoarthritis, First Monoclonal Antibody Drug for Use in Any Animal Species

FDA Approves Novel Treatment to Control Pain in Cats with Osteoarthritis, First Monoclonal Antibody Drug for Use in Any Animal…

FDA Releases Federal Interagency Working Group Scientific Opinions on Testing Methods for Asbestos in Talc-Containing Cosmetic Products

Interagency Working Group on Asbestos in Consumer Products (IWGACP) White Paper offers opinions on testing methods of talc-containing cosmetics products…

Update on Risk of Type III Endoleaks with Use of Endologix AFX Endovascular AAA Graft Systems – FDA Safety Communication

Do not routinely use AFX2 endovascular grafts for patients with abdominal aortic aneurysms. Original source: http://www.fda.gov/medical-devices/safety-communications/update-risk-type-iii-endoleaks-use-endologix-afx-endovascular-aaa-graft-systems-fda-safety-0

Oscor Inc. Issues Voluntary Worldwide Recall of Destino Twist Steerable Guiding Sheath Due to the Risk of the Device Hub Cap and Seal on the Proximal End of the Device Handle Detachment During Use

Oscor Inc. is voluntarily recalling 14 lots of Destino Twist 14F model DST1405525 & Guidestar 14F model D141103 down to…

Buprenorphine: Drug Safety Communication – FDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain

FDA is warning that dental problems have been reported with medicines containing buprenorphine that are dissolved in the mouth. Original…

Lohxa LLC Issues Voluntary Nationwide Recall of Senna Syrup 8.8mg/5mL Due to Microbial Contamination

Lohxa LLC is voluntarily recalling one lot of Senna Syrup 8.8mg/5mL, unit-dose cups to the consumer level. The product is…

FDA Roundup: January 11, 2022

The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. Original source: http://www.fda.gov/news-events/press-announcements/fda-roundup-january-11-2022

2022 Safety Communications

Listing of Medical Device 2022 Safety Communications Original source: http://www.fda.gov/medical-devices/safety-communications/2022-safety-communications

Stop Using LuSys Laboratories COVID-19 Tests: FDA Safety Communication

The tests are likely to have a high risk of false results and are not FDA authorized, cleared, or approved.…