Home / Recalls / Dercher Enterprises, Inc., DBA Gordon Laboratories / D-1528-2019

D-1528-2019 Class II Terminated

Recalled by Dercher Enterprises, Inc., DBA Gordon Laboratories — Upper Darby, PA

Recall Details

Product Type: Drugs
Report Date: July 31, 2019
Initiation Date: July 19, 2019
Termination Date: August 14, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 277 boxes

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

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 Pattern

Nationwide in the USA

Code Information

Batch #: 579634, 579635, Exp 5/2020