The topical anesthetic was found to be “super potent,” which could lead to systemic toxicity and central nervous system and cardiovascular reactions.
Teligent Pharma is voluntarily recalling two additional lots of Lidocaine HCl topical solution 4%. The product is being recalled because the firm’s testing has found it to be super potent.
Use of the super potent product would result in a higher than intended lidocaine dose above that intended. An increased lidocaine dose could lead to the development of local anesthetic systemic toxicity, 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 toxicity is not recognized and treated quickly, severe morbidity and even death can result. Adults and the elderly, 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 has not received any reports of adverse events related to this recall.
The product is used for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract.
It is packaged in a 50ml glass bottle with a screw cap, and was distributed at the wholesale and retail distribution levels in the United States and Canada.
The lots impacted by this recall have an NDC of 63739-997-64. One lot, 15594, had an expiration of May 2023, and the second lot, 16345, had an expiration of January 2024.
In October, Teligent had recalled five lots of lidocaine for the same issue of super potency. The lots impacted by the October recall include:
• NDC 52565-009-50
Lot number 13262, with an expiration of March 2022
Lot number 14217, with an expiration of August 2022
Lot number 13058, with an expiration of February 2022
Lot number 13768, with an expiration of May 2022
• NDC 63739-997-64
Lot number 16306, with an expiration of January 2024
In September, Teligent recalled one lot of lidocaine with the NDC 52565-009-50, lot number 14218, with the expiration date of September 2022.