Reported Jun 20, 2018 · Terminated
Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box,…
BioDiagnostic International
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: BioDiagnostic International · 555 W Lambert Rd Ste C · Brea, CA · 92821-3917
Is this the product you have?
- Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box
- Manufactured ForMedGyn Products, Inc., 100 W. Industrial Rd., Addison, IL 60101 USA
- Manufactured By
BioDiagnostics Intl555 West Lambert Road Unit-CBreaCA 92821NDC 42721-112-08
- Lot codes and dates
- All lots within expiry
- Amount recalled
- 1000 boxes
Where it was sold
- Nationwide
- IL
Why it was recalled
CGMP Deviations: Products not manufactured under current good manufacturing practices.
This product could cause temporary or reversible health problems — stop using it.
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