The FDA announced today that Teligent Pharma has issued world wide recall of lidocaine topical solution 4% because they found, at 18 months, that it was far stronger than originally intended. There is a chance that this solution has been, or is currently being, used in bladder instillations. This “super potent” lidocaine would result in a higher than intended lidocaine dose and could lead to the development of local anesthetic systemic toxicity and cardiovascular symptoms. 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. To date, Teligent Pharma, Inc. has not received any reports of adverse events related to this recall.
Read the full announcement here!
