- Company Announcement Date:
- August 08, 2019
- FDA Publish Date:
- August 08, 2019
- Product Type:
- Reason for Announcement:
Recall Reason Description
Microbiological Contamination and Superpotency
- Company Name:
- Ridge Properties LLC DBA Pain Relief Naturally
- Brand Name:
TAT Balm, Naturally HL
- Product Description:
4% Lidocaine topical cream & liquid gel products
Ridge Properties LLC DBA Pain Relief Naturally is voluntarily recalling 4 lots of 4% lidocaine topical cream & liquid gel products sold at the consumer level. FDA analysis has found these products to have microbiological contamination and the potency is higher than the labeled amount for lidocaine.
The risks from a contaminated pre-tattoo product are greater since the skin is being traumatized immediately after application and tattooing is known to have infectious complications. Additionally, use of lidocaine greater than the label claim may increase the risk of methemoglobinemia, a blood disorder in which an abnormal amount of methemoglobin is produced.. To date, the company has not received any reports of adverse events related to this recall.
PRE-TAT is marketed as a numbing agent/topical anesthetic used prior to tattoo application. Soothing Sore Relief is marketed for soothing relief of pain and/or itch associated with hemorrhoids and bedsores. Superior pain and itch relief is marketed as a numbing agent/topical anesthetic. Lots & expiration dates are listed on a gold colored expiration sticker on the back of the products. Products were distributed nationwide through online sales at the following websites: amazon.com, ebay.com, walmart.com, tatbalm.net, & naturallyhl.com. These products are used as a topical anesthetic and are packaged in black jars or bottles with metallic red or green lettering. The affected products include the following lot numbers and expiration dates:
The product can be identified by the above stated names and descriptions. Lots & expiration dates are listed on a gold colored expiration sticker on the back of the product. Products were distributed Nationwide through online sales at the following websites: amazon.com, ebay.com, walmart.com, tatbalm.net, & naturallyhl.com. No products from these lots are currently for sale, or in stock at company or any of it’s distributors.
Company is notifying its customers by press release, and recall letter and is arranging for replacement of all recalled products. Consumers that have products of the specified lot numbers which are being recalled should stop using, discard or return with recall response form, and reach out to the company for a replacement using the recall response form which can be emailed to [email protected], or mailed to the following address.
Pain Relief Naturally Recall Department
4995 Ridge Dr NE
Salem, OR, 97301
Consumers with questions regarding this recall can contact company by phone at (1- 877-906-4806) 9 am – 5 pm Monday-Friday, pacific time, or by email at [email protected] Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products. A recall response form will be included in recall letter to consumers, or can be printed from www.tatbalm.net or www.naturallyhl.com. Consumers should include the quantity of returned items on the recall response form irregardless of whether products are returned or discarded.