Medgyn Products, Inc. recalls Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box,
Medgyn Products recalls Monsel's Solution 20% (12 vials) due to failure to meet current good manufacturing practices. No specific remedy is stated in the recall notice.
Recall notice
CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
Contact the company & request your remedy
What happened, in plain English
Medgyn Products is recalling Monsel's Solution 20% (12 single-use vials) because the product was not manufactured under current good manufacturing practices. This issue means the product may not meet safety standards, but the recall does not specify a remedy. Read more at govinfonow.com/recall/40384-medgyn-monsel-s-solution-20-recall-cgmp-manufacturing-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/40384-medgyn-monsel-s-solution-20-recall-cgmp-manufacturing-issues · Updated October 6, 2026 · FDA enforcement record: FDA #D-0917-2018
Cite this page
“Medgyn Monsel's Solution 20% Recall: CGMP Manufacturing Issues.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/40384-medgyn-monsel-s-solution-20-recall-cgmp-manufacturing-issues. Based on FDA recall #D-0917-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0917-2018%22&limit=1).
Why it’s dangerous
The product was not manufactured under current good manufacturing practices (CGMP), which are strict quality standards for pharmaceuticals. This could mean the product is unsafe or inconsistent, but the recall does not specify how this affects safety.
Who’s affected
Users of Monsel's Solution 20% (12 vial packages) manufactured by Medgyn Products are affected. People using this product for medical purposes may be at risk due to potential quality issues.
How to tell if you have this one
Check for Monsel's Solution 20% (12 single application vials) with NDC 42721-112-08. The product was manufactured by BioDiagnostics Intl and distributed by Medgyn Products.
- Brand
Medgyn Products- Category
Drug
What to do — step by step
Check Product Details
Identify if your product matches the description: Monsel's Solution 20% (12 vials) with NDC 42721-112-08.
Questions people ask
Is there a remedy for this recall?
The recall notice does not specify any remedy.
What is the hazard with this product?
The product was not manufactured under current good manufacturing practices (CGMP), which could affect quality and safety.
How can I tell if I have the recalled product?
Look for Monsel's Solution 20% (12 single application vials) with NDC 42721-112-08, manufactured by BioDiagnostics Intl and distributed by Medgyn Products.
Contact Medgyn Products
We’ve drafted a message you can send Medgyn Products to request your refund or repair — edit it as you like.
Subject: Recall D-0917-2018 — Medgyn Products Medgyn Products Hello, I own a Medgyn Products that is covered by recall D-0917-2018 from Medgyn Products. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0917-2018 (July 3, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0917-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.