Drug product
Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
D-0165-2018
Product summary
- Event
- Event 78553
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,530 jars
- Official record key
drug-enforcement:D-0165-2018
Official wording
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Code information: Lots: 06072017@22 BUD: 12/4/2017; 06222017@30 BUD: 12/19/2017; 08032017@31 BUD: 1/30/2018; 09212017@21 BUD: 3/20/2018; 10232017@20 BUD: 11/22/2017
Distribution pattern: Nationwide in the USA, Bermuda, and New Zealand
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing