Drug 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.
D-0917-2018
Product summary
- Event
- Event 80309
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2750 boxes
- Official record key
drug-enforcement:D-0917-2018
Official wording
Reason: CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
Code information: Lot #s: all lots within expiry
Distribution pattern: 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.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations