Monsel's recall: Sterility Concern
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.
Why was Monsel's 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch #: 579634, 579635, Exp 5/2020
- 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.
- Recalling firm
- Dercher Enterprises, Inc., DBA Gordon Laboratories
- Quantity
- 277 boxes
- Distribution
- Nationwide in the USA
- Recall date
- July 31, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)