Fresenius Medical Care Renal Therapies Group product recalled over sterility concerns

Recall date

November 13, 2017

Source

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

Official notice title

Fresenius Medical Care Renal Therapies Group, LLC recalls 0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 492…

Recall number

D-0827-2018

FDA classification

Class II

Brand / firm

Fresenius Medical Care Renal Therapies Group, LLC

Sold / distributed

Product was distributed throughout the United States.

Why it was recalled

Lack of Assurance of Sterility

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

What was recalled

0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.