# FDA recall D-1317-2015

> **GlaxoSmithkline Consmer Healthcare** · Class II · drug recall initiated 2015-07-15.

## Product

biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, South Jordan, UTAH 84095, Distributed by GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108, NDC 0135-0488-01

## Reason for recall

Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.

## Distribution

Nationwide, Puerto Rico & Taiwan

## Key facts

- **Recall number:** D-1317-2015
- **Recalling firm:** GlaxoSmithkline Consmer Healthcare
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-07-15
- **Report date:** 2015-08-19
- **Termination date:** 2017-04-19

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1317-2015

## Citation

> AI Analytics. FDA recall D-1317-2015. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1317-2015. Source: US FDA. Licensed CC0.

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