How FDA drug recalls work
Topical creams and gels meant to take some of the pain out of tattoos, hemorrhoids and some of the itching out of bedsores have been recalled after the FDA says it found microbial contamination and too much lidocaine in the products.
Ridge Properties, which does business under the “Pain Relief Naturally” name, pulled lot No. 1213 with an expiration date of 6/05/23 of Pre-TAT in Liquid Gel and Superior Pain & Itch Relief in Liquid Gel; lot No. 1222 with an expiration date of 6/14/23 of Pre-TAT in Cream and Superior Pain & Itch Relief in Cream; lot No. 1228 with an expiration date of 06/21/23 of Soothing Sore Relief in Cream; and lot No. 1135 with an expiration date of 12/27/22 of Soothing Sore Relief.
The lot numbers and expiration dates are on a gold expiration sticker. All of these come in 1-ounce, 2-ounce and 4-ounce jars.
Pre-TAT is used as a numbing agent before tattoos. Superior is also a numbing agent. Soothing Sore Relief is for dealing with the pain and itching associated with hemorrhoids and bedsores, respectively.
All these creams and gels are stated to have four percent lidocaine, but the FDA says it found a higher percentage. That’s in addition to the microbial contamination.
“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,” the company-written, FDA-posted recall notice states. “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.”
These over-the-counter creams and gels were sold online via amazon.com, walmart.com, ebay.com, tatbalm.net and naturallyhl.com.
Those who have these products should stop using them and either toss them out or return them. Contact the company via phone at 1-877-906-4806, noon to 8 p.m., Eastern time, Monday through Friday; via email at email@example.com; or by snail mail at Pain Relief Naturally Recall Department, 4995 Ridge Dr. NE, Salem, OR, 97301.