Baxter Healthcare Corporation recalls 10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter Healthcare Corporation, Clintec…

Recall date

December 6, 2016

Source

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

Recall number

D-0425-2017

FDA classification

Class II

Brand / firm

Baxter Healthcare Corporation

Sold / distributed

US

Why it was recalled

Discoloration: there were customer reports of yellow discolored solution. The yellow coloration is the result of oxidation of the amino acid tryptophan due to a damaged overpouch.

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

What was recalled

10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx only, Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 USA, NDC 0338-1130-06