Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis

Recall date

October 9, 2018

Source

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

Recall number

Z-0516-2019

FDA classification

Class III

Brand / firm

Fresenius Medical Care Renal Therapies Group, LLC

Sold / distributed

Distribution US nationwide and Mexico

Why it was recalled

Discolored powder has confirmed the presence of a foreign substance

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg 16.5 GAL Catalog Number: OFD2201-3B for hemodialysis