Medications & Supplements/Prescription Drugs

Gordon Laboratories: Monsel's (Ferric Subsulfate) Solution Recalled for High Iron Levels

Agency Publication Date: December 17, 2018

Summary

Gordon Laboratories is recalling 1,155 boxes of Monsel's (Ferric Subsulfate) Solution, a prescription topical medication, because it contains higher levels of iron than stated on the label. This superpotent formulation means patients are receiving a more concentrated dose of the drug than intended by their physician. The affected product was distributed nationwide in 8 mL amber glass bottles, packaged in boxes of one dozen bottles with applicators.

Risk

The higher-than-labeled iron concentration makes the drug superpotent, which can lead to unpredictable clinical results or localized tissue irritation when applied during medical procedures. While no injuries have been reported to date, the inconsistency in potency poses a risk to patient safety and treatment efficacy.

What You Should Do

Check your medical supplies for Monsel's (Ferric Subsulfate) Solution in 8 mL amber glass bottles with NDC 10481-0112-8.
Verify the batch and expiration details on the packaging: look for Batch # 579602 (Exp 12/18), 579604 (Exp 12/18), 579606 (Exp 12/18), or 579609 (Exp 04/19).
Immediately stop using any bottles matching these batch numbers and set them aside to ensure they are not used on patients.
Contact your healthcare provider or pharmacist for guidance regarding this recall and to arrange for an alternative supply.
Return any unused product from the affected batches to your pharmacy or place of purchase for a refund.
Contact Gordon Laboratories at their Upper Darby, PA location for further instructions regarding the return or disposal of the product.
For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare guidance and product refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Monsel's (Ferric Subsulfate) Solution (8 mL)

Model:

NDC 10481-0112-8

Lot Numbers:

579602 (Exp 12/18)

579604 (Exp 12/18)

579606 (Exp 12/18)

579609 (Exp 04/19)

579602

Date Ranges: Exp 12/18, Exp 04/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81719

Status: Resolved

Manufacturer: Gordon Laboratories

Sold By: Physician offices; Hospitals; Pharmacies

Manufactured In: United States

Units Affected: 1,155 boxes

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Check your medical supplies for Monsel's (Ferric Subsulfate) Solution in 8 mL amber glass bottles with NDC 10481-0112-8.

Verify the batch and expiration details on the packaging: look for Batch # 579602 (Exp 12/18), 579604 (Exp 12/18), 579606 (Exp 12/18), or 579609 (Exp 04/19).

Immediately stop using any bottles matching these batch numbers and set them aside to ensure they are not used on patients.

Contact your healthcare provider or pharmacist for guidance regarding this recall and to arrange for an alternative supply.

Return any unused product from the affected batches to your pharmacy or place of purchase for a refund.

Contact Gordon Laboratories at their Upper Darby, PA location for further instructions regarding the return or disposal of the product.

For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.