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.
Recall initiated: 20190719
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated