FDA-Drug2019-09-25Class II
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.
Ridge Properties, LLC
Hazard
Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
Sold states
Nationwide in the USA via internet sales through Amazon.com; ebay.com; Walmart.com; tatbalm.net; Naturallyhl.com
Affected count
109.64 ounces total
Manufactured in
4995 Ridge Dr NE, N/A, Salem, OR, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1857-2019Don't want to check this manually?
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