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: July 31, 2019 Initiated: July 19, 2019 #D-1528-2019
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
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.
Details
- Recalling Firm
- Dercher Enterprises, Inc., DBA Gordon Laboratories
- Units Affected
- 277 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 Dercher Enterprises, Inc., DBA Gordon Laboratories. Units affected: 277 boxes.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 31, 2019. Severity: Moderate. Recall number: D-1528-2019.
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