Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles wit...
FDA Recall #D-0338-2019 — Class II — December 10, 2018
Product Description
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.
Reason for Recall
Superpotent Drug: contains higher levels of Iron than labeled.
Recalling Firm
Gordon Laboratories — Upper Darby, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1,155 boxes
Distribution
Nationwide in the USA.
Code Information
Batch #: 579602, 579604, 579606, Exp 12/18; 579609, Exp 04/19.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated