Brea, CA, United States
BioDiagnostic International recalls
1 recall recorded since 2018, most recently on 11 June 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 11 June 2018
- Terminated
- 25 July 2019
- Reason
- CGMP Deviations: Products not manufactured under current good manufacturing practices.
- Distribution
- Product was distributed to one sole customer in Illinois who further distributed Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0874-2018
- 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 B
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.