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 Lam

FDA recall notice · announced June 20, 2018 · Biodiagnostic

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Reason for recall

CGMP Deviations: Products not manufactured under current good manufacturing practices.

Notes

Distribution: Product was distributed to one sole customer in Illinois who further distributed Nationwide in the USA.
Lot/code information: All lots within expiry
Quantity: 1000 boxes
Status: Terminated
Products in this recall event:
- 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 (D-0874-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.