Medications & Supplements/Prescription Drugs

Dercher Enterprises, Inc., DBA Gordon Laboratories: MONSEL'S Ferric Subsulfate Solution Recalled for Microbial Contamination

Agency Publication Date: July 25, 2019

Summary

Dercher Enterprises, Inc., doing business as Gordon Laboratories, is recalling 277 boxes of MONSEL'S (Ferric Subsulfate) Solution, a prescription medication used to stop bleeding after certain medical procedures. The recall was initiated because FDA testing found microbial contamination and excessively high levels of iron that do not meet safety specifications. Using a contaminated topical solution on open skin or during medical procedures can lead to serious infections or adverse reactions.

Risk

The product is contaminated with microorganisms and has iron content that is 'superpotent,' meaning it exceeds the safe and intended dosage levels. This poses a significant risk of infection or skin irritation, especially when applied to broken skin or surgical sites.

What You Should Do

Check your medical supplies for MONSEL'S (Ferric Subsulfate) Solution in 8 mL amber glass bottles, sold in boxes of 12 with applicators.
Verify the batch and lot numbers on the packaging: look for Batch # 579634 or 579635, and Lot 579634 with an expiration date of May 2020 (Exp 5/2020).
Confirm the National Drug Code (NDC) matches 10481-0112-8.
Immediately stop using the affected product and secure it to prevent further use.
Contact your healthcare provider or pharmacist for guidance if you have used this product or have concerns about a recent procedure where it may have been applied.
Return any unused product to the place of purchase for a refund and contact Gordon Laboratories at their Upper Darby, PA location for further instructions.
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

Refund for prescription medication

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:

579634

Batch 579634 (Exp 5/2020)

Batch 579635 (Exp 5/2020)

Date Ranges: Exp 5/2020

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83399

Status: Resolved

Manufacturer: Dercher Enterprises, Inc., DBA Gordon Laboratories

Sold By: Authorized distributors

Manufactured In: United States

Units Affected: 277 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

What You Should Do

Check your medical supplies for MONSEL'S (Ferric Subsulfate) Solution in 8 mL amber glass bottles, sold in boxes of 12 with applicators.

Verify the batch and lot numbers on the packaging: look for Batch # 579634 or 579635, and Lot 579634 with an expiration date of May 2020 (Exp 5/2020).

Confirm the National Drug Code (NDC) matches 10481-0112-8.

Immediately stop using the affected product and secure it to prevent further use.

Contact your healthcare provider or pharmacist for guidance if you have used this product or have concerns about a recent procedure where it may have been applied.

Return any unused product to the place of purchase for a refund and contact Gordon Laboratories at their Upper Darby, PA location for further instructions.

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.