FDAFDA · Food and drugs·Recall number D-0917-2018
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.
Published July 18, 2018 · Recall initiated: July 3, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
What to do
Voluntary: Firm initiated
Recall details
- Manufacturer
- Medgyn Products, Inc.
- Distributor
- 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.
- Lot
- Lot #s: all lots within expiry
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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