Drug 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 -
D-019-2014
Product summary
- Event
- Event 66012
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 g - 11403 units; 14 g - 7338 units 14 g kit - 200 units
- Official record key
drug-enforcement:D-019-2014
Official wording
Reason: 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.
Code information: Lot 470 exp. 04/13, 471 exp. 06/13, 472 exp. 10/13
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Subpotent