Reported Jul 18, 2018 · Terminated
Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box,…
Medgyn Products, Inc.
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: Medgyn Products, Inc. · 100 W Industrial Rd · Addison, IL · 60101-4508
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
- Lot #s: all lots within expiry
- Amount recalled
- 2750 boxes
Where it was sold
- Nationwide
- GA
Why it was recalled
CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
This product could cause temporary or reversible health problems — stop using it.
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