# FDA recall D-1307-2019

> **Septodont Inc.** · Class II · drug recall initiated 2019-05-02.

## Product

Articaine DENTAL, Articane hydrochloride 4% and epinephrine 1:100,000,   50 cartridges. 1.7 mL each, Rx only, Manufactured for: DENTSPLY Pharmaceutical, by Novocol Pharmaceutical of Canada, Inc. York, PA 17404, NDC 66312-601-16 Reorder #: 51116

## Reason for recall

Labeling: Not Elsewhere Classified. This recall has been initiated due to mislabeling. The printed carton used in manufacturing both batches contained text for both 2% Xylocaine DENTAL and Articadent DENTAL. Xylocaine DENTAL is a trade name for Lidocaine HCL 2% and Epinephrine 1: 100,000 formulation, while Articadent DENTAL is a trade name for Articaine HCI 4% and Epinephrine 1 :100,000. The cartridges contained within the  printed carton are labeled appropriately as Articadent DENTAL.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1307-2019
- **Recalling firm:** Septodont Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-05-02
- **Report date:** 2019-05-29
- **Termination date:** 2020-11-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Louisville, CO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1307-2019

## Citation

> AI Analytics. FDA recall D-1307-2019. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/D-1307-2019. Source: US FDA. Licensed CC0.

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