Based on its review of postmarket clinical trial data, the U.S. Food and Drug Administration (FDA) identified cases of serious liver injury among patients being treated for primary biliary cholangitis (PBC) with Ocaliva (obeticholic acid) who did not have cirrhosis of the liver.

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program

Monoject U-100 1 ml Insulin Syringe Luer-Lock with Tip Cap Soft Pack is used for IV insulin. Certain lots are incompatible with needleless connectors.