Drug & medication recalls Moderate risk

PRE-TAT 3 in 1 Pre Tattoo Prep With Lidocaine Liquid Gel recalled over sterility concerns

Recall date
August 9, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Ridge Properties, LLC recalls 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…
Recall number
D-1857-2019
FDA classification
Class II
Brand / firm
Ridge Properties, LLC
Sold / distributed
Nationwide in the USA via internet sales through Amazon.com; ebay.com; Walmart.com; tatbalm.net; Naturallyhl.com

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.

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