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.
Reported: December 26, 2018 Initiated: December 10, 2018 #D-0338-2019
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.
Details
- Recalling Firm
- Gordon Laboratories
- Units Affected
- 1,155 boxes
- Distribution
- Nationwide in the USA.
- Location
- Upper Darby, PA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Gordon Laboratories. Units affected: 1,155 boxes.
Why was this product recalled? ▼
Superpotent Drug: contains higher levels of Iron than labeled.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 26, 2018. Severity: Moderate. Recall number: D-0338-2019.
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