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Recall Observatory FDA recall evidence

Drug 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.

D-1856-2019

August 09, 2019

Class II

Product summary

Firm
Ridge Properties, LLC
Event
Event 83538
Status
Terminated
Classification
Class II
Quantity
383.65 ounces total
Official record key
drug-enforcement:D-1856-2019

Official wording

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

Code information: Lot # 1222, Exp 06/14/2023

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

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial Contamination