MONSEL'S Solution recalled over sterility concerns

Recall date

July 19, 2019

Source

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

Official notice title

Dercher Enterprises, Inc., DBA Gordon Laboratories recalls MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box,…

Recall number

D-1528-2019

FDA classification

Class II

Brand / firm

Dercher Enterprises, Inc., DBA Gordon Laboratories

Sold / distributed

Nationwide in the USA

Why it was recalled

Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron content.

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.