FDAClass IISeptember 25, 2019

Pre-tat recall: Sterility Concern

PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Cream, 4%, packaged in a) 1 OZ (NDC 69804-002-05), b) 2 OZ (NDC 69804-002-02), and c) 4 OZ (NDC 69804-002-03) jars, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.

Why was Pre-tat recalled?

Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 1222, Exp 06/14/2023

Product
PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Cream, 4%, packaged in a) 1 OZ (NDC 69804-002-05), b) 2 OZ (NDC 69804-002-02), and c) 4 OZ (NDC 69804-002-03) jars, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.
Recalling firm
Ridge Properties, LLC
Quantity
383.65 ounces total
Distribution
Nationwide in the USA via internet sales through Amazon.com; ebay.com; Walmart.com; tatbalm.net; Naturallyhl.com
Recall date
September 25, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls