Medication Recall: Lidocaine Topical Solution Pulled For 'Super Potency'

A company is recalling one lot of its Lidocaine topical solution after learning of its "super potency." This means using the product may result in a higher dose of lidocaine than intended.

The problem was discovered after testing yielded an "out of specification (OOS) result," the company announced on the U.S. Food and Drug Administration (FDA) website. Lidocaine topical ointment or jelly is typically used on different parts of the body to cause numbness after certain procedures or to relieve pain or itching.

Teligent Pharma's Lidocaine HCl Topical Solution (4%) is indicated to produce topical anesthesia for "accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract." However, super potency may result in certain health effects, particularly among adults and the elderly, as well as children who have lower body weight.

"An increased lidocaine dose could lead to the development of local anesthetic systemic toxicity depending on the duration of the treatment and the specific patient," the company noted. "Local anesthetic systemic toxicity can result in central nervous system reactions including excitation and/or depression and more serious signs of cardiovascular toxicity, such as bradycardia, hypotension, and even cardiovascular collapse can present very quickly. If local anesthetic systemic toxicity is not recognized and treated quickly, severe morbidity and even death can result."

Local anesthetic systemic toxicity rates happen in about 1 per 1,000 peripheral nerve blocks, the Anesthesia Patient Safety Foundation (APSF) said. However, it's also possible that the rates may be higher because of under-reporting or misdiagnoses.

The company has not received reports of adverse events related to the recalled products, but those who have already purchased it should return the item to where it was bought from.

The recalled product has the label that reads "Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL)" and has the lot number 14218 and expiry date 09/2022. They come in 50 ml glass bottles with screw caps with the identification NDC# 52565-009-50.

The products were distributed to wholesale and retail outlets in the U.S. and Canada.

"Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product," the company said.