Drug 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.
D-0874-2018
Product summary
- Event
- Event 80277
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1000 boxes
- Official record key
drug-enforcement:D-0874-2018
Official wording
Reason: CGMP Deviations: Products not manufactured under current good manufacturing practices.
Code information: All lots within expiry
Distribution pattern: Product was distributed to one sole customer in Illinois who further distributed Nationwide in the USA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations