Monsel's Solution recalled over manufacturing violations

Recall date

June 11, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

BioDiagnostic International recalls Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, M…

Recall number

D-0874-2018

FDA classification

Class II

Brand / firm

BioDiagnostic International

Sold / distributed

Product was distributed to one sole customer in Illinois who further distributed Nationwide in the USA.

Why it was recalled

CGMP Deviations: Products not manufactured under current good manufacturing practices.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.