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  4. 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
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COMPANY ANNOUNCEMENT

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

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Summary

Company Announcement Date:
FDA Publish Date:
Product Type:
Drugs
Reason for Announcement:
Recall Reason Description
Microbiological Contamination and Superpotency
Company Name:
Ridge Properties LLC DBA Pain Relief Naturally
Brand Name:
Brand Name(s)
TAT Balm, Naturally HL
Product Description:
Product Description
4% Lidocaine topical cream & liquid gel products

Company Announcement

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.


Company Contact Information

Consumers:
1- 877-906-4806
prncustomercare@gmail.com

Product Photos

 
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