Medications & Supplements/Topical Products

Medgyn Products, Inc.: Monsel's Solution Recalled for Manufacturing Practice Deviations

Agency Publication Date: July 11, 2018

Summary

Medgyn Products, Inc. has recalled 2,750 boxes of Monsel's Solution (Ferric Subsulfate), 20%, a liquid medication used to stop bleeding after minor surgical procedures. This recall was initiated because the product was not manufactured according to Current Good Manufacturing Practices (CGMP), which means the quality and safety of the solution cannot be guaranteed. Consumers should contact their healthcare provider or pharmacist regarding any use of this product and return any remaining supply to the place of purchase.

Risk

Failure to follow good manufacturing practices can result in products that are contaminated, ineffective, or have incorrect ingredient concentrations, potentially leading to infections or failure to control bleeding during medical procedures.

What You Should Do

Check your medical supplies for Monsel's Solution (Ferric Subsulfate), 20%, packaged in boxes of 12 single-application 8 mL vials with 12 applicators.
Verify the identifying codes: Look for NDC 42721-112-08 and Recall # D-0917-2018 on the packaging. All lot numbers that are currently within their expiration date are affected.
Immediately stop using the affected solution and quarantine any remaining stock you have.
Contact your healthcare provider or pharmacist for guidance if you have recently used this product or have concerns about its effects.
Return any unused product to the pharmacy or place of purchase for a refund and contact Medgyn Products, Inc. for further instructions.
Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

Full 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 Solution (Ferric Subsulfate), 20% (8 mL per box)

Model:

NDC 42721-112-08

Recall # D-0917-2018

Lot Numbers:

all lots within expiry

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80309

Status: Resolved

Manufacturer: Medgyn Products, Inc.

Sold By: Authorized medical distributors

Manufactured In: United States

Units Affected: 2750 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 Solution (Ferric Subsulfate), 20%, packaged in boxes of 12 single-application 8 mL vials with 12 applicators.

Verify the identifying codes: Look for NDC 42721-112-08 and Recall # D-0917-2018 on the packaging. All lot numbers that are currently within their expiration date are affected.

Immediately stop using the affected solution and quarantine any remaining stock you have.

Contact your healthcare provider or pharmacist for guidance if you have recently used this product or have concerns about its effects.

Return any unused product to the pharmacy or place of purchase for a refund and contact Medgyn Products, Inc. for further instructions.

Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.