FDA recall D-019-2014

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

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

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