Recalls / Class II
Class IID-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 -
- Brand name
- Cetacaine Anesthetic
- Generic name
- Benzocaine, Butamben, And Tetracaine Hydrochloride
- Active ingredients
- Benzocaine, Butamben, Tetracaine Hydrochloride
- Route
- Topical
- NDCs
- 10223-0202, 10223-0225, 10223-0226
- Affected lot / code info
- Lot 470 exp. 04/13, 471 exp. 06/13, 472 exp. 10/13
Why it was recalled
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.
Recalling firm
- Firm
- Cetylite Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9051 River Road, N/A, Pennsauken, New Jersey 08110-3203
Distribution
- Quantity
- 30 g - 11403 units; 14 g - 7338 units 14 g kit - 200 units
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-04-02
- FDA classified
- 2013-11-26
- Posted by FDA
- 2013-12-04
- Terminated
- 2014-08-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-019-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.