Cetacaine Anesthetic Solution
FDA Recall NDC 10223-0202
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Cetacaine Anesthetic (NDC 10223-0202). A significant event, classified as Class II, was initiated on Apr 02, 2013 by Cetylite Industries, Inc.. The reported reason for this action was: "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."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
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.
Apr 02, 2013
Dec 04, 2013
30 g - 11403 units; 14 g - 7338 units 14 g kit - 200 units
Recall Profile & Regulatory Data
Event ID
66012
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cetylite Industries, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Aug 01, 2014
Product Description
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 -
Batch or Lot Expiration Information
Lot# Lot 470 exp. 04/13, 471 exp. 06/13, 472 exp. 10/13
Affected Packages Involved in this Recall
10223-0202-2Product
10223-0202-4Product
10223-0202-5Product
10223-0202-6Product
10223-0202-7Product
10223-0202-8Product
10223-0225-1Product
10223-0226-1Product
10223-0202-3Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
