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.
D-1528-2019
Product summary
- Event
- Event 83399
- Status
- Terminated
- Classification
- Class II
- Quantity
- 277 boxes
- Official record key
drug-enforcement:D-1528-2019
Official wording
Reason: 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.
Code information: Batch #: 579634, 579635, Exp 5/2020
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Microbial contamination
Microbial Contamination
-
Potency or specification failure
Superpotent