Teligent Pharma has recalled five lots of lidocaine hydrochloride topical solution because it may be "super potent."

A New Jersey pharmaceutical company is recalling some lots of its lidocaine hydrochloride topical solution because it may be “super potent.” N-Isopropylbenzylamine

According to an announcement with the U.S. Food and Drug Administration, Teligent Pharma has recalled five lots of lidocaine because testing found it to be too strong.

Using a product that is super potent, the FDA said, “would result in a higher than intended lidocaine dose above” what was intended.

Lidocaine is intended “for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract.”

In the announcement, the FDA said toxicity could occur which “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. Adults and the elderly who are more likely to use this product as well as children of lower body weight are more likely to experience local anesthetic systemic toxicity if a higher than intended lidocaine concentration is administered.”

The recalled product details are:

It was distributed to wholesalers and retailers nationwide in the United States and in Canada.

For more information, people can call 856-697-1441 and press * to reach the medical information call center between 8 a.m. and 5 p.m. weekdays or send an email to medical@teligent.com.

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