D-0874-2018 Class II Terminated
FDA drug recall D-0874-2018 was initiated by BioDiagnostic International on June 11, 2018 and is designated Class II. Reason for recall: CGMP Deviations: Products not manufactured under current good manufacturing practices. The recall status is terminated (terminated July 25, 2019). Affected quantity: 1000 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- June 20, 2018
- Initiation Date
- June 11, 2018
- Termination Date
- July 25, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1000 boxes
Product Description
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.
Reason for Recall
CGMP Deviations: Products not manufactured under current good manufacturing practices.
Distribution Pattern
Product was distributed to one sole customer in Illinois who further distributed Nationwide in the USA.
Code Information
All lots within expiry