FDA recall D-1856-2019

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.

Reason for recall

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

Distribution

Nationwide in the USA via internet sales through Amazon.com; ebay.com; Walmart.com; tatbalm.net; Naturallyhl.com

Key facts

Status

Terminated

Initiation date

2019-08-09

Report date

2019-09-25

Termination date

2023-07-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salem, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1856-2019