FDAJuly 19, 2019drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

dercher enterprises inc dba gordon laboratoriesdercherdercher enterprises

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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