# FDA recall D-019-2014

> **Cetylite Industries, Inc.** · Class II · drug recall initiated 2013-04-02.

## Product

Cetacaine Liquid Topical Anesthetic,  Rx Only, a) 14 g bottle (NDC 10223-0202-2); Kit w/14 g (NDC 10223-0202-3); 30 g bottle (NDC 10223-0202-4) Manufactured by Cetylite Industries, Inc., 9051 River Road Pennsauken, NJ 08110       -

## Reason for recall

Subpotent Drug: Cetacaine Topical Anesthetic Liquid is being recalled because one of the three active ingredients, tetracaine, is below the specification limit  at the 21 month stability test point.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-019-2014
- **Recalling firm:** Cetylite Industries, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-04-02
- **Report date:** 2013-12-04
- **Termination date:** 2014-08-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Pennsauken, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-019-2014

## Citation

> AI Analytics. FDA recall D-019-2014. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-019-2014. Source: US FDA. Licensed CC0.

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