Ridge Properties, LLC, issued a recall of 4% lidocaine topical cream & liquid gel products like PRE-TAT and SUPERIOR Pain and Itch Relief, sold at the consumer level.
The products are being recalled due to Microbiological Contamination and Superpotency.
These products are used as a topical anesthetic and are packaged in black jars or bottles with metallic red or green lettering.
Products were distributed nationwide through online sales at the following websites: amazon.com, ebay.com, walmart.com, tatbalm.net, & naturallyhl.com.
The products being recalled include:
PRE-TAT– a numbing agent/topical anesthetic used before applying the tattoo.
The risk from using a contaminated product on skin before a tattoo are greater than normal since the skin is traumatized right after application.
Also, the tattooing process itself can have infectious complications. Introducing more microbiological contamination really increases the risk for getting those complications along with the tattoo.
Soothing Sore Relief Cream– marketed for soothing pain and/or itching associated with hemorrhoids and bedsores.
Superior Pain and Itch Relief– marketed as a numbing agent and topical anesthetic.
The potency of lidocaine in these products is higher than the amount written on the label.
The problem with using a greater potency of lidocaine is the increased risk of methemoglobinemia, a blood disorder that involves the production of abnormal amounts of methemoglobin.
The FDA website has a full list of the recalled products, with their lot numbers and expiration dates.
To date, the company has not received any reports of adverse events related to this recall.
No products from the contaminated lots are currently for sale, or in stock at company or any of its distributors.
The company is notifying its customers by press release and recall letter, and is arranging for replacement of all recalled products.
If you have one of the products with the specified lot number, stop using the product and discard it.
You can also return the product and use the recall response form to reach out to the company for a replacement. Email the form to email@example.com, or use snail mail to send it to the following address:
Pain Relief Naturally Recall Department
4995 Ridge Dr NE
Salem, OR, 97301
Forms will be sent to you if you have bought this product recently.
If you have questions regarding this recall, contact the company by phone at 877-906-4806, 9 am – 5 pm Monday-Friday, pacific time, or by email at firstname.lastname@example.org.
If you used the recalled product, and have experienced problems, talk to your healthcare provider. Adverse reactions or quality problems experienced with the use of this product can also 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
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