FDA recall D-1528-2019

Dercher Enterprises, Inc., DBA Gordon Laboratories · Class II · drug

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

Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron content.

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2019-07-19
Report date: 2019-07-31
Termination date: 2023-08-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Upper Darby, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1528-2019