FDA-Drug2013-12-04Class II

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 -

Cetylite Industries, Inc.
Hazard

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.

Sold states
Nationwide
Affected count
30 g - 11403 units; 14 g - 7338 units 14 g kit - 200 units
Manufactured in
9051 River Road, N/A, Pennsauken, NJ, United States
Products
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 -

Official notice

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

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