Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream packaged in jars, Rx Only, KRS Global B...
FDA Recall #D-0166-2018 — Class II — November 16, 2017
Product Description
Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical 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
1,380 jars
Distribution
Nationwide in the USA, Bermuda, and New Zealand
Code Information
Lots: 07142017@31 BUD: 1/10/2018; 09202017@22 BUD: 3/19/2018; 10042017@25 BUD: 4/2/2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated