FDA Recalls Lidocaine HCl Topical Solution USP, 4% by Teligent Pharma

  • by AGD Staff
  • Dec 13, 2021
12-13-21_FDAOn Dec. 8, the Food and Drug Administration (FDA) issued an announcement for an urgent recall of two lots of Teligent Pharma Lidocaine HCl Topical Solution USP, 4% - 50 ml. Dentists should stop using product from lots 16345 and 15594 immediately. 

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. 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 and hypotension, and even cardiovascular collapse can present quickly. If local anesthetic systemic toxicity is not recognized and quickly treated, severe morbidity and even death can result. 

To date, Teligent Pharma has not received any reports of adverse events related to this recall. Health professionals are encouraged to report adverse events or side effects related to the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.