PlainRecalls
FDA Drug Moderate Class II Terminated

PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-019-14), b) 2 Oz (NDC 69804-019-15), and c) 4 Oz (NDC 69804-019-16) bottles, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.

Reported: September 25, 2019 Initiated: August 9, 2019 #D-1857-2019

Product Description

PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-019-14), b) 2 Oz (NDC 69804-019-15), and c) 4 Oz (NDC 69804-019-16) bottles, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.

Reason for Recall

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

Details

Recalling Firm
Ridge Properties, LLC
Units Affected
109.64 ounces total
Distribution
Nationwide in the USA via internet sales through Amazon.com; ebay.com; Walmart.com; tatbalm.net; Naturallyhl.com
Location
Salem, OR

Frequently Asked Questions

What product was recalled? ▼
PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-019-14), b) 2 Oz (NDC 69804-019-15), and c) 4 Oz (NDC 69804-019-16) bottles, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.. Recalled by Ridge Properties, LLC. Units affected: 109.64 ounces total.
Why was this product recalled? ▼
Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 25, 2019. Severity: Moderate. Recall number: D-1857-2019.

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