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Four lots of 4% lidocaine topical cream and liquid gel products involved.
August 9, 2019
By: Melissa Meisel
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 and naturallyhl.com. No products from these lots are currently for sale, or in stock at company or any of its distributors. The products involved include select SKUs: PreTAT in Cream by TAT BALM 3 in 1 Pre-Tattoo Prep with Lidocaine, Lot 1222, Expiration 06/14/23 PreTAT in Liquid Gel by TAT BALM 3 in 1 Pre-Tattoo Prep with Lidocaine, Lot 1213, Exp. 06/05/23 Superior Pain & Itch Releif in Cream, Lot 1222, Exp. 06/14/23 Superior Pain & Itch Releif in Liquid Gel, Lot 1213, Exp. 06/05/23 Soothing Sore Releif in Cream Fast Acting of Pain and Itching Associated with Minor Sores in Cream, Lot 1228, Exp. 06/21/23 Soothing Sore Relief In Liquid Gel Fast Acting Relief of Pain and Itching Associated with Minor Sores in Liquid Gel, Lot 1135, Exp. 12/27/22 More info: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/ridge-properties-llc-dba-pain-relief-naturally-issues-voluntary-nationwide-recall-pre-tat-superior-0
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