BioDiagnostic International recalls Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Ma
Recalled June 20, 2018 · FDA recall D-0874-2018 · BioDiagnostic International
Hazard
CGMP Deviations: Products not manufactured under current good manufacturing practices. · FDA Class II
Units
1000 boxes
Sold at
Product was distributed to one sole customer in Illinois who further distributed Nationwide in the USA.
Description
CGMP Deviations: Products 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)
BioDiagnostic International
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →