Recalls / Class II
Class IID-1861-2019
Product
Soothing Sore Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-077-14), b) 2 Oz (NDC 69804-077-15), and c) 4 Oz (NDC 69804-077-16) bottles, OTC, Manufactured, packed & distributed by Pain Relief Naturally, Salem, OR 97301.
- Affected lot / code info
- Lot # 1135, Exp 12/27/2022
Why it was recalled
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
Recalling firm
- Firm
- Ridge Properties, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 4995 Ridge Dr NE, N/A, Salem, Oregon 97301-7475
Distribution
- Quantity
- 104.1 ounces
- Distribution pattern
- Nationwide in the USA via internet sales through Amazon.com; ebay.com; Walmart.com; tatbalm.net; Naturallyhl.com
Timeline
- Recall initiated
- 2019-08-09
- FDA classified
- 2019-09-13
- Posted by FDA
- 2019-09-25
- Terminated
- 2023-07-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1861-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.