Clinimix E 5/20 sulfite-free Injection recalled over sterility concerns

Recall date

March 23, 2015

Source

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

Official notice title

Baxter Healthcare Corp recalls Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual…

Recall number

D-0428-2015

FDA classification

Class II

Brand / firm

Baxter Healthcare Corp

Sold / distributed

Nationwide and Singapore

Why it was recalled

Lack of Assurance of Sterility; increased complaints received for leaks

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose with calcium) Injection, 2000 mL in Dual Chamber Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- Product code 2B7722, NDC 0338-1125-04