Voluntary recall issued for lidocaine cream and liquid gel products
Lidocaine topical cream and liquid gel products are being recalled as the lidocaine amount is higher than the label states.
Ridge Properties LLC DBA Pain Relief Naturally is voluntarily recalling four lots of 4 percent lidocaine topical cream and liquid gel products as US Food and Drug Administration (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 traumatised immediately after application and tattooing is known to have infectious complications. Additionally, the use of lidocaine greater than the label claim may increase the risk of methemoglobinemia.
The recalled products are as follows:
- PRE-TAT, which is marketed as a numbing agent/topical anesthetic used prior to tattoo application
- Soothing Sore Relief, which is marketed for soothing relief of pain and/or itching associated with hemorrhoids and bedsores
- Superior Pain and Itch Relief which is marketed as a numbing agent/topical anesthetic.
A full list of the product names, descriptions and volume sizes, as well as lot numbers, expiration dates and distribution sources can be found here.
Lots and expiration dates are listed on a gold-coloured expiration sticker on the back of the products. These products are used as a topical anesthetic and are packaged in black jars or bottles with metallic red or green lettering.
The company has said it 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 a recall response form, and reach out to the company for a replacement.”
To date, the company has stated to the FDA that it has not received any reports of adverse events related to this recall.