New information about M. chimaera infections, and updated recommendations to help prevent the spread of infection.

Excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury or death.

FDA requiring a Boxed Warning about the risk of HBV reactivation to be added to drug labels, directing health care professionals to screen and monitor for HBV in all patients receiving DAA treatment.

Bacteria and/or particulate matter present in an unsterile solution could pass through to a compounded prepared solution, which could lead to adverse health consequences.