Topical Products Recalled

Pharmaceutical Technology Editors

Ridge Properties LLC DBA Pain Relief Naturally is voluntarily recalling four lots of 4% lidocaine topical cream and liquid gel products due to microbiological contamination and incorrect potency.

Ridge Properties LLC DBA Pain Relief Naturally announced on Aug. 8, 2019 that it was voluntarily recalling four lots of 4% lidocaine topical cream and liquid gel products because FDA analysis found microbiological contamination and incorrect potency. According to FDA, the potency is higher than the label amount for lidocaine.

The recalled products include PreTAT, which is used as a numbing agent and topical anesthetic prior to the application of a tattoo. According to the company, use of contaminated product prior to receiving a tattoo could result in infection.

The company also states that using lidocaine that is more potent than intended “may increase the risk of methemoglobinemia, a blood disorder in which an abnormal amount of methemoglobin is produced.” 

According to the company, no adverse events have been reported. A complete list of recalled products may be found on FDA.gov. Adverse events may be reported through the agency’s MedWatch program.

Source: FDA