Monsel's Solution — Class II drug recall D-0917-2018
Terminated recall by Medgyn Products, Inc., reported 2018-07-18, distributed nationwide. CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current go
| Recall number | D-0917-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medgyn Products, Inc., Addison, IL, United States |
| Recall initiated | 2018-07-03 |
| Classified | 2018-07-11 |
| Reported by FDA | 2018-07-18 |
| Terminated | 2020-09-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BB, CL, CY, EC, GT, HK, KW, KY, LB, MX, MY, PE, PK, PY, RS, SV, VE, VN, ZA |
| Quantity | 2,750 boxes |
| Reason classes | cgmp |
| NDC | 42721-0112-08 |
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.
Reason for recall
CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0917-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.