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-0338-2019
Product summary
- Event
- Event 81719
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,155 boxes
- Official record key
drug-enforcement:D-0338-2019
Official wording
Reason: Superpotent Drug: contains higher levels of Iron than labeled.
Code information: Batch #: 579602, 579604, 579606, Exp 12/18; 579609, Exp 04/19.
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Superpotent