Gericare Iron Supplement Elixir Ferrous Sulfate recalled over manufacturing violations

Recall date

May 31, 2019

Source

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

Official notice title

Geritrex, LLC recalls Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals…

Recall number

D-1523-2019

FDA classification

Class II

Brand / firm

Geritrex, LLC

Sold / distributed

U.S.A. Nationwide

Why it was recalled

cGMP Deviations: Products may have microbial contamination.

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

What was recalled

Gericare Iron Supplement Elixir Ferrous Sulfate, 220 mg, 16 fl oz. (473 mL), Distributed by: Geri-care Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-709-16