Monsel's Solution — Class II drug recall D-0874-2018
Terminated recall by BioDiagnostic International, reported 2018-06-20, distributed nationwide. CGMP Deviations: Products not manufactured under current good manufacturing practices.
| Recall number | D-0874-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BioDiagnostic International, Brea, CA, United States |
| Recall initiated | 2018-06-11 |
| Classified | 2018-06-14 |
| Reported by FDA | 2018-06-20 |
| Terminated | 2019-07-25 |
| Distributed | Nationwide (US) |
| Quantity | 1,000 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: Products 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-0874-2018. 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.