Medgyn Products, Inc. recalls Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Ma
Recalled July 18, 2018 · FDA recall D-0917-2018 · Medgyn Products
Hazard
CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices. · FDA Class II
Units
2750 boxes
Sold at
Nationwide in the USA, Barbados, Cayman Islands, Chile, Cyprus, Ecuador, El Salvador, Guatemala, Hong Kong, Kuwait, Lebanon, Malaysia, Maldives, Mexico, Mongolia, Montenegro, Mozambique, Pakistan, Paraguay, Peru, Republic of Georgia, Serbia, South Africa, Tanzania, United Arab Emirates, Venezuela, and Vietnam.
Description
CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
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.
Manufacturer(s)
Medgyn Products, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →