Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-1115-04

Recall Number: D-0301-2015

Firm: Baxter Healthcare Corp.

Classification: Class II

Status: Terminated

Report Date: 20141224

Initiation Date: 20141125

Termination Date: 20151028

Lack of Assurance of Sterility; leaks were observed from the bag seam and port seal

Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injections, in CLARITY Dual Chamber Container, Baxter Healthcare Corporation, Deerfield, IL NDC 0338-1115-04