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
Product summary
- 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
Microbial Contamination