Summary Company Announcement Date: April 19, 2021 FDA Publish Date: April 19, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potentially weakened plastic Company Name: Tenacore LLC Brand Name: Brand Name(s) Tenacore LLC Product Description: Product Description 2001 Tenacore Replacement CareFusion Alaris 8100 bezels Company Announcement On February 24th, 2021, Tenacore LLC…
Infant Formula: Safety Do’s and Dont’s
[embedded content] Español The Food and Drug Administration (FDA) oversees manufacturers of infant formulas and helps ensure that these products are safe and support healthy growth in infants who consume them. Don’t Make Homemade Formula The FDA advises parents and caregivers to not make or feed homemade infant formula to infants. Homemade infant formula recipes…
FDA D.I.S.C.O. Burst Edition: Enhertu (fam-trastuzumab deruxtecan-nxki ) and combination of Opdivo (nivolumab) and Cabometyx (cabozantinib)
Podcast Welcome back to the DISCO, 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’ll provide a quick update on two recent FDA cancer drug approvals. On January 15, 2021, FDA approved fam-trastuzumab deruxtecan-nxki (brand name…
Medtronic Perfusion Systems Recalls Bio-Console 560 Extracorporeal Blood Pumping Console for Possible Electrical Failure Causing the Pump to Stop
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 Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console (Bio-Console 560) Models: 560BC, 560BCS, 560BC1, 560BCS1, R560BCS1 Serial Numbers: Please See Links Below. Distribution Dates: April 1, 2019 to…
Lo que debe saber sobre el cáncer colorrectal
Image English El año pasado, en los Estados Unidos, se diagnosticó a más de 136,000 personas con cáncer colorrectal, y más de 50,000 murieron a causa de esta enfermedad, según el Instituto Nacional del Cáncer. El cáncer colorrectal es la segunda causa de muerte relacionada con el cáncer en los Estados Unidos, y algunos grupos…
FDA D.I.S.C.O. Burst Edition: Tepmetko (tepotinib) and Ukoniq (umbralisib)
Podcast Welcome back 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’ll provide another quick update on two recent FDA cancer drug approvals. On February 3, 2021, the FDA granted accelerated approval to…
BD Announces the Voluntary Recall of Specified Lots of ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator in the United States and U.S. Territories Due to Defective Applicator
Summary Company Announcement Date: April 20, 2021 FDA Publish Date: April 20, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Defective applicator Company Name: Becton, Dickinson and Company Brand Name: Brand Name(s) ChloraPrep Product Description: Product Description ChloraPrep™ Hi-Lite Orange™ 26 mL Applicator Company Announcement BD (Becton, Dickinson and Company), a leading global…
Church & Dwight Initiates Voluntary Recall of Select Vitamins Due to Isolated Manufacturing Issue
Summary Company Announcement Date: April 20, 2021 FDA Publish Date: April 20, 2021 Product Type: Food & Beverages Reason for Announcement: Recall Reason Description May contain metallic mesh material Company Name: Church & Dwight Co., Inc. Brand Name: Brand Name(s) Vitafusion Product Description: Product Description Gummy vitamin products Company Announcement EWING, N.J – Church &…
Colorectal Cancer: What You Should Know About Screening
Image The evidence is clear – screening for colorectal cancer may save your life. Today, more and more people are choosing colorectal cancer screening. As a result, there is a steady decline in the number of older people getting and dying from colorectal cancer. Lower rates of smoking among Americans have also contributed to the…
Tenacore Recalls Alaris Pump Bezel Assembly and Alaris Infusion Pumps repaired with Bezel Assembly Due to Possible Cracked or Separated Bezel Repair Posts
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 Alaris Infusion Pumps serviced by Tenacore Models: Model 8100 Serial Numbers: Please See Link Below. Distribution Dates: July 10, 2020 to February 18, 2021 Devices Recalled in…