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: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
Recall initiated: 20180703
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated