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Benzo/Lido/Tetracaine 20%-8%-8% Topical Cream packaged in jars, Rx Only, KRS Global Biotechnology...

FDA Recall #D-0167-2018 — Class II — November 16, 2017

Recall #D-0167-2018 Date: November 16, 2017 Classification: Class II Status: Terminated

Product Description

Benzo/Lido/Tetracaine 20%-8%-8% 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

3,280 jars

Distribution

Nationwide in the USA, Bermuda, and New Zealand

Code Information

Lots: 06072017@38 BUD: 12/4/2017; 07062017@48 BUD: 1/2/2018; 08012017@23 BUD: 1/28/2018; 08212017@36 BUD: 2/17/2018; 09182017@26 BUD: 3/17/2018

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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