April 2013 FDA Recall Cetacaine Anesthetic by Cetylite Industries, Inc.
D-019-2014 - Subpotent Drug
This Class II drug recall was voluntarily initiated by Cetylite Industries, Inc. on April 2, 2013 for the product Cetacaine Anesthetic. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-019-2014
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.
04-02-2013
12-04-2013
30 g - 11403 units; 14 g - 7338 units 14 g kit - 200 units
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Cetylite Industries, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
08-01-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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 -
Batch or Lot Expiration Information
Lot# Lot 470 exp. 04/13, 471 exp. 06/13, 472 exp. 10/13
