Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Monsel's Solution (Ferric Subsulfate) Recalled by Medgyn Products, Inc. Due to CGMP Deviations: The manufacturer of this product recalled...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medgyn Products, Inc. directly.
Affected Products
Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: MedGyn Products, Inc., 100 W. Industrial Rd., Addison, IL 60101 USA; Manufactured By: BioDiagnostics Intl, 555 West Lambert Road Unit-C, Brea, CA 92821, NDC 42721-112-08.
Quantity: 2750 boxes
Why Was This Recalled?
CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medgyn Products, Inc.
Medgyn Products, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report