Baxter Healthcare Corp. recalls CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injectio…

Recall date

January 21, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0864-2016

FDA classification

Class I

Brand / firm

Baxter Healthcare Corp.

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

Presence of Particulate Matter: identified as dried skin.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injection Port Chamber 30% Dextrose Injection with Calcium, 1000 mL Outlet Port Chamber 10% Amino Acid Injection with Electrolytes, 2000 mL CLARITY Dual Chamber Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B7721, NDC 0338-1123-04.