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.
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 -
Lot numbers, UPCs & expiration codes
Lot 470 exp. 04/13, 471 exp. 06/13, 472 exp. 10/13
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-019-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 2, 2013
- FDA report date
- Dec 4, 2013
- Quantity
- 30 g - 11403 units; 14 g - 7338 units 14 g kit - 200 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Cetylite Industries, Inc.
Original FDA data
Every field from FDA enforcement report D-019-2014, exactly as published.
Show all FDA fields
- City
- Pennsauken
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 66012
- Address
- 9051 River Road
- Code information
- Lot 470 exp. 04/13, 471 exp. 06/13, 472 exp. 10/13
- Postal code
- 08110-3203
- Report date
- Dec 4, 2013
- Product type
- Drugs
- Recall number
- D-019-2014
- Classification
- Class II
- Recalling firm
- Cetylite Industries, Inc.
- Product quantity
- 30 g - 11403 units; 14 g - 7338 units 14 g kit - 200 units
- Termination date
- Aug 1, 2014
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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 -
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 2, 2013
- Initial firm notification
- Letter
- Center classification date
- Nov 26, 2013