FDA recall D-0917-2018

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.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2018-07-03

Report date

2018-07-18

Termination date

2020-09-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Addison, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0917-2018