FDA-Drug2018-06-20Class 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.
BioDiagnostic International
Hazard
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Sold states
Product was distributed to one sole customer in Illinois who further distributed Nationwide in the USA.
Affected count
1000 boxes
Manufactured in
555 W Lambert Rd Ste C, N/A, Brea, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0874-2018Don't want to check this manually?
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