Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global Biotechno...
FDA Recall #D-0165-2018 — Class II — November 16, 2017
Product Description
Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream packaged in jars, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Reason for Recall
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.
Recalling Firm
KRS Global Biotechnology, Inc — Boca Raton, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
4,530 jars
Distribution
Nationwide in the USA, Bermuda, and New Zealand
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated