Topical Creams Recalled Due to Contamination

August 16, 2019

Products marketed as a numbing agent/topical anesthetic used prior to tattoo application.

Topical creams-including lidocaine-are being recalled from major retailers’ web sites due to microbiological contamination. 

Ridge Properties LLC DBA Pain Relief Naturally is voluntarily recalling 4 lots of 4% lidocaine topical cream and liquid gel products. “FDA analysis has found these products to have microbiological contamination and the potency is higher than the labeled amount for lidocaine,” says Ridge in a statement posted on FDA’s web site.

The creams and gels were distributed nationwide via Amazon, eBay, walmart.com, and other web sites.

The recalled PRE-TAT in Cream by TAT Balm 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.

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“The risks from a contaminated pre-tattoo product are greater since the skin is being traumatized immediately after application… 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,” Ridge says.

However, Ridge has not received any reports of adverse events related to the recall.

A full list of recalled products and expiration dates is available here.

Ridge is notifying its customers by press release and recall letter and is arranging for replacement of all recalled products. Consumers who have the recalled products should stop using them, discard them, or return them with a recall response form and reach out to the company for a replacement.

 

Adverse reactions or quality problems experienced with the use of the products may be reported to the FDA's MedWatch Adverse Event Reporting program.