Reported Dec 26, 2018 · Terminated

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

Gordon Laboratories

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Gordon Laboratories · 6801 Ludlow St · Upper Darby, PA · 19082-2408

Is this the product you have?

  • 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.
Lot codes and dates
    • Batch #: 579602
    • 579604
    • 579606
    • Exp 12/18
    • 579609
    • Exp 04/19
Amount recalled
1,155 boxes

Where it was sold

  • Nationwide

Why it was recalled

Superpotent Drug: contains higher levels of Iron than labeled.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 2, 2020 · Data as of Sep 19, 8:34 PM UTC

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