FDA Recall Terminated Historical recordClass II
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
- CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
- Published
- July 18, 2018
- Distribution
- Nationwide
