Gordon Laboratories recalls Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box,…

Recall date

December 10, 2018

Source

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

Recall number

D-0338-2019

FDA classification

Class II

Brand / firm

Gordon Laboratories

Sold / distributed

Nationwide in the USA.

Why it was recalled

Superpotent Drug: contains higher levels of Iron than labeled.

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

What was recalled

Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.