Drug recall D-019-2014
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 -
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.
Lots and codes
Lot 470 exp. 04/13, 471 exp. 06/13, 472 exp. 10/13
Recall details
- Recalling firm
- Cetylite Industries, Inc., Pennsauken, NJ
- Quantity
- 30 g - 11403 units; 14 g - 7338 units 14 g kit - 200 units
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- April 2, 2013
- Terminated
- August 1, 2014
Related products
- Cetacaine Anesthetic – drug information
- NDC 10223-0202 Cetacaine Anesthetic · Benzocaine .028 g/.2g; Butamben .004 g/.2g; Tetracaine… · Cetylite Industries, Inc.
- NDC 10223-0226 Cetacaine Anesthetic · Benzocaine .028 g/.2g; Butamben .004 g/.2g; Tetracaine… · Cetylite Industries, Inc.
- NDC 10223-0225 Cetacaine Anesthetic · Benzocaine .028 g/.2g; Butamben .004 g/.2g; Tetracaine… · Cetylite Industries, Inc.