Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg recalled over manufacturing violations

Recall date

May 7, 2018

Source

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

Official notice title

RIJ Pharmaceutical LLC recalls Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz. (473 mL) bottles, Dist by: Gericare Pharm…

Recall number

D-0853-2018

FDA classification

Class II

Brand / firm

RIJ Pharmaceutical LLC

Sold / distributed

Nationwide in the USA

Why it was recalled

CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.

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, packaged in 16 fl oz. (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-709-16, UPC 57896709167