D-1856-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 25, 2019
- Initiation Date
- August 9, 2019
- Termination Date
- July 12, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 383.65 ounces total
Product Description
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 Pattern
Nationwide in the USA via internet sales through Amazon.com; ebay.com; Walmart.com; tatbalm.net; Naturallyhl.com
Code Information
Lot # 1222, Exp 06/14/2023