FDA recall D-0338-2019

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.

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2018-12-10

Report date

2018-12-26

Termination date

2020-12-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Upper Darby, PA, United States

Primary source

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