# FDA recall D-923-2013

> **Novocol Pharmaceutical of Canada** · Class II · drug recall initiated 2013-08-14.

## Product

Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, Rx Only, For Dental Block and Infiltration Only, 50 Cartridges per box - 1.7 mL minimum each,  NDC #s: a) Octocaine 100, Mfr'ed for Septodont, Louisville, CO, 80027, by Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada N1R6X3, 0362-9023-05; b) Superdent, Dist by: Darby Dental Supply Co., Jericho, NY 11753, Made in Canada,  66467-9730-5; and c) Dist by: IQ Dental, 353 Rt 46 W, Bldg C Unit 120, Fairfield, NJ, 07004, made in Canada, 42756-1030-5; Manufactured by: by Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada N1R6X3.

## Reason for recall

Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under the names: Octocaine 100, and 2% Xylocaine Dental, may be subpotent for the epinephrine component.

## Distribution

Nationwide and Canada

## Key facts

- **Recall number:** D-923-2013
- **Recalling firm:** Novocol Pharmaceutical of Canada
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-08-14
- **Report date:** 2013-09-04
- **Termination date:** 2014-01-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cambridge, Canada

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-923-2013

## Citation

> AI Analytics. FDA recall D-923-2013. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-923-2013. Source: US FDA. Licensed CC0.

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