Monsel's recall: Superpotent
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?
Superpotent Drug: contains higher levels of Iron than labeled.
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 #: 579602, 579604, 579606, Exp 12/18; 579609, Exp 04/19.
- 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
- Gordon Laboratories
- Quantity
- 1,155 boxes
- Distribution
- Nationwide in the USA.
- Recall date
- December 26, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)