BioDiagnostic International recalls Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box,
BioDiagnostic International recalls Monsel's Solution (20% Ferric Subsulfate) due to CGMP deviations. Products packaged as 12 vials and 12 applicators, 8mL per box, manufactured for MedGyn Products. No remedy specified in recall notice.
Recall notice
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Contact the company & request your remedy
What happened, in plain English
BioDiagnostic International has recalled Monsel's Solution (20% Ferric Subsulfate) vials and applicators due to manufacturing issues that don't meet current good manufacturing practices. This recall affects products sold under the NDC code 42721-112-08. The issue means the product may not be safe for use as intended. Read more at govinfonow.com/recall/40492-biodiagnostic-international-recalls-monsel-s-solution-for-cgmp-manufacturing-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/40492-biodiagnostic-international-recalls-monsel-s-solution-for-cgmp-manufacturing-issues · Updated October 7, 2026 · FDA enforcement record: FDA #D-0874-2018
Cite this page
“BioDiagnostic International recalls Monsel's Solution for CGMP manufacturing issues.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40492-biodiagnostic-international-recalls-monsel-s-solution-for-cgmp-manufacturing-issues. Based on FDA recall #D-0874-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0874-2018%22&limit=1).
Why it’s dangerous
The product was manufactured without following current good manufacturing practices, which means it may not be safe for use. This could lead to potential quality issues with the product, but the specific risk to health or safety isn't clearly described in the recall notice.
Who’s affected
People who own or use Monsel's Solution (20% Ferric Subsulfate) vials and applicators manufactured for MedGyn Products. Those who have the product from the specific NDC code 42721-112-08 are most at risk.
How to tell if you have this one
Check for Monsel's Solution (20% Ferric Subsulfate) packaged as 12 single application vials and 12 applicators, 8 mL per box. The product was manufactured for MedGyn Products, Inc. with NDC code 42721-112-08.
- Brand
BioDiagnostic International- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 42721-112-08 on the product packaging to confirm it's part of this recall.
Questions people ask
Is there a remedy for this product?
The recall notice does not specify any remedy.
What is the specific product being recalled?
Monsel's Solution (20% Ferric Subsulfate) packaged as 12 single application vials and 12 applicators, 8 mL per box.
Who manufactured this product?
BioDiagnostic International manufactured the product for MedGyn Products, Inc.
Contact BioDiagnostic International
We’ve drafted a message you can send BioDiagnostic International to request your refund or repair — edit it as you like.
Subject: Recall D-0874-2018 — BioDiagnostic International BioDiagnostic International Hello, I own a BioDiagnostic International that is covered by recall D-0874-2018 from BioDiagnostic International. 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-0874-2018 (June 11, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0874-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.