FDAFDA · Food and drugs·Recall number D-1528-2019
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.
Published July 31, 2019 · Recall initiated: July 19, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Dercher Enterprises, Inc., DBA Gordon Laboratories
- Distributor
- Nationwide in the USA
- Lot
- Batch #: 579634, 579635, Exp 5/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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