Teligent Pharma has voluntarily recalled two lots of Lidocaine HCl Topical Solution USP 4% because testing found it to be “super potent.”
People could be using a higher than intended dose of the lidocaine, which could lead to “local anesthetic systemic toxicity,” according to an announcement with the U.S. Food and Drug Administration.
“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. 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 lidocaine, which comes in a 50mL glass bottle, was distributed to wholesalers and retailers nationwide.
The product details are:
- Lidocaine Hydrochloride Topical Solution USP 4%, 50mL bottle, NDC number 63739-997-64 with lot number 15594 and an expiration date of May 2023; and lot number 16345 with an expiration date of January 2024.
People who have the lidocaine solution are asked to stop using it and call 856-697-1441 between 8 a.m. and 5 p.m. weekdays or send an email to medical@teligent.com to receive instructions for returning it and reimbursement.
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