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.

FDA recall notice · announced December 26, 2018 · Gordon Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: Nationwide in the USA.
Lot/code information: Batch #: 579602, 579604, 579606, Exp 12/18; 579609, Exp 04/19.
Quantity: 1,155 boxes
Status: Terminated
Products in this recall event:
- 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. (D-0338-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.