FDAJuly 3, 2018drug
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 4272...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
What to do
FDA enforcement status: Terminated
Brands named
medgyn productsmedgyn
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAHydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T32026-04-24
- FDAPremier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufacturer: Premier Medical Products, 1710 Romano Drive, Plymouth Meeting, PA 19462, NDC 48783-112-08.2026-04-14
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