D-019-2014 Class II Terminated
FDA drug recall D-019-2014 was initiated by Cetylite Industries, Inc. on April 2, 2013 and is designated Class II. 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. The recall status is terminated (terminated August 1, 2014). Affected quantity: 30 g - 11403 units; 14 g - 7338 units 14 g kit - 200 units.
Recall Details
- Product Type
- Drugs
- Report Date
- December 4, 2013
- Initiation Date
- April 2, 2013
- Termination Date
- August 1, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30 g - 11403 units; 14 g - 7338 units 14 g kit - 200 units
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 -
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 Pattern
Nationwide
Code Information
Lot 470 exp. 04/13, 471 exp. 06/13, 472 exp. 10/13