Ridge Properties LLC DBA Pain Relief Naturally Issues Voluntary Nationwide Recall of PRE-TAT , Superior Pain and Itch Relief, and Soothing Sore Relief Cream and Gel Products Due to Microbiological Contamination and Superpotency
Audience: Consumer, Health Professional, Pharmacy
August 8, 2019 -- 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:
| Product | Lot | Expiration | Volume | Package | Distributed Through |
|---|---|---|---|---|---|
| PreTAT in Cream by TAT BALM 3 in 1 Pre-Tattoo Prep with Lidocaine | 1222 | 06/14/23 | 1,2, & 4 ounce jars | black jars with metallic red lettering | Amazon.com ebay.com walmart.com tatbalm.net |
| PreTAT in Liquid Gel by TAT BALM 3 in 1 Pre-Tattoo Prep with Lidocaine | 1213 | 06/05/23 | 1,2, & 4 ounce jars | black jars with metallic red lettering | Amazon.com ebay.com walmart.com tatbalm.net |
| Superior Pain & Itch Releif in Cream | 1222 | 06/14/23 | 1,2, & 4 ounce jars | black jars with metallic green lettering | Amazon.com ebay.com walmart.com Naturallyhl.com |
| Superior Pain & Itch Releif in Liquid Gel | 1213 | 06/05/23 | 1,2, & 4 ounce jars | black jars with metallic green lettering | Amazon.com ebay.com walmart.com Naturallyhl.com |
| Soothing Sore Releif in Cream Fast Acting of Pain and Itching Associated with Minor Sores in Cream | 1228 | 06/21/23 | 1,2, & 4 ounce jars | black jars with metallic green lettering | Amazon.com ebay.com walmart.com Naturallyhl.com |
| Soothing Sore Releif In Liquid Gel Fast Acting Releif of Pain and Itching Associated with Minor Sores in Liquid Gel | 1135 | 12/27/22 | 1,2, & 4 ounce jars | black jars with metallic green lettering | Amazon.com ebay.com walmart.com Naturallyhl.com |
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 prncustomercare@gmail.com, 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 prncustomercare@gmail.com 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.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Source: FDA
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.