D-0338-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 26, 2018
- Initiation Date
- December 10, 2018
- Termination Date
- December 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,155 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
Superpotent Drug: contains higher levels of Iron than labeled.
Distribution Pattern
Nationwide in the USA.
Code Information
Batch #: 579602, 579604, 579606, Exp 12/18; 579609, Exp 04/19.