Product: 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.
Recall initiated: 20190809
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated