# FDA recall D-0243-2017

> **Gentell, Inc** · Class II · drug recall initiated 2016-12-15.

## Product

Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04

## Reason for recall

CGMP Deviations

## Distribution

United States

## Key facts

- **Recall number:** D-0243-2017
- **Recalling firm:** Gentell, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-12-15
- **Report date:** 2017-01-11
- **Termination date:** 2018-02-16

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0243-2017

## Citation

> AI Analytics. FDA recall D-0243-2017. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0243-2017. Source: US FDA. Licensed CC0.

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