# FDA recall D-1528-2019

> **Dercher Enterprises, Inc., DBA Gordon Laboratories** · Class II · drug recall initiated 2019-07-19.

## Product

MONSEL'S (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box, Rx only, Gordon Laboratories, Upper Darby, PA 19082, NDC 10481-0112-8.

## Reason for recall

Microbial Contamination of Non-Sterile Products and Superpotent Drug: FDA analysis revealed microbial contamination in addition to high out of specification results for iron content.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1528-2019
- **Recalling firm:** Dercher Enterprises, Inc., DBA Gordon Laboratories
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-07-19
- **Report date:** 2019-07-31
- **Termination date:** 2023-08-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Upper Darby, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1528-2019

## Citation

> AI Analytics. FDA recall D-1528-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1528-2019. Source: US FDA. Licensed CC0.

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