Drug product
Soothing Sore Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 69804-074-05), b) 2 OZ (NDC 69804-074-02), and c) 4 OZ (NDC 69804-074-03) jars, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.
D-1860-2019
Product summary
- Event
- Event 83538
- Status
- Terminated
- Classification
- Class II
- Quantity
- 136 ounces
- Official record key
drug-enforcement:D-1860-2019
Official wording
Reason: Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Code information: Lot # 1228, Exp 06/21/2023
Distribution pattern: Nationwide in the USA via internet sales through Amazon.com; ebay.com; Walmart.com; tatbalm.net; Naturallyhl.com
Derived failure modes
-
Potency or specification failure
Superpotent