D-0917-2018 Class II Terminated
FDA drug recall D-0917-2018 was initiated by Medgyn Products, Inc. on July 3, 2018 and is designated Class II. Reason for recall: CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices. The recall status is terminated (terminated September 28, 2020). Affected quantity: 2750 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- July 18, 2018
- Initiation Date
- July 3, 2018
- Termination Date
- September 28, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2750 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: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
Distribution Pattern
Nationwide in the USA, Barbados, Cayman Islands, Chile, Cyprus, Ecuador, El Salvador, Guatemala, Hong Kong, Kuwait, Lebanon, Malaysia, Maldives, Mexico, Mongolia, Montenegro, Mozambique, Pakistan, Paraguay, Peru, Republic of Georgia, Serbia, South Africa, Tanzania, United Arab Emirates, Venezuela, and Vietnam.
Code Information
Lot #s: all lots within expiry