# FDA recall D-0917-2018

> **Medgyn Products, Inc.** · Class II · drug recall initiated 2018-07-03.

## 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.

## Distribution

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.

## Key facts

- **Recall number:** D-0917-2018
- **Recalling firm:** Medgyn Products, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-07-03
- **Report date:** 2018-07-18
- **Termination date:** 2020-09-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Addison, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0917-2018

## Citation

> AI Analytics. FDA recall D-0917-2018. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/D-0917-2018. Source: US FDA. Licensed CC0.

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