FDA-Drug2018-12-26Class II

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.

Gordon Laboratories
Hazard

Superpotent Drug: contains higher levels of Iron than labeled.

Sold states
Nationwide in the USA.
Affected count
1,155 boxes
Manufactured in
6801 Ludlow St, Upper Darby, PA, United States
Products
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 notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0338-2019

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