Cetacaine Liquid Topical Anesthetic — Class II drug recall D-019-2014
Terminated recall by Cetylite Industries, Inc., reported 2013-12-04, distributed nationwide. Subpotent Drug: Cetacaine Topical Anesthetic Liquid is being recalled because one of the three active ingredie
| Recall number | D-019-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cetylite Industries, Inc., Pennsauken, NJ, United States |
| Recall initiated | 2013-04-02 |
| Classified | 2013-11-26 |
| Reported by FDA | 2013-12-04 |
| Terminated | 2014-08-01 |
| Distributed | Nationwide (US) |
| Reason classes | potency, specification failure |
| NDC | 10223-0202, 10223-0202-02, 10223-0202-03, 10223-0202-04, 10223-0202-05, 10223-0202-06, 10223-0202-07, 10223-0202-08, 10223-0225, 10223-0225-01, 10223-0226, 10223-0226-01 |
| Lot numbers | 04/13, 06/13, 10/13, 470, 471, 472 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-019-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.