# FDA recall D-0874-2018

> **BioDiagnostic International** · Class II · drug recall initiated 2018-06-11.

## 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.

## Distribution

Product was distributed to one sole customer in Illinois who further distributed Nationwide in the USA.

## Key facts

- **Recall number:** D-0874-2018
- **Recalling firm:** BioDiagnostic International
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-06-11
- **Report date:** 2018-06-20
- **Termination date:** 2019-07-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brea, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0874-2018

## Citation

> AI Analytics. FDA recall D-0874-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0874-2018. Source: US FDA. Licensed CC0.

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