Teligent Pharma is recalling five lots of Lidocaine HCl Topical Solution 4%, 50mL, because the firm’s testing has found it to be super potent based on an Out of Specification result obtained at the 18-month stability timepoint.
Use of the super potent product would result in a higher than intended lidocaine dose. 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, hypotension and even cardiovascular collapse. If local anesthetic systemic toxicity is not recognized and treated quickly, severe morbidity and even death can result.
Adults, the elderly who are more likely to use this product and 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.
Units of Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle being recalled include the following:
NDC 52565-009-50, Lot #13262, expiration March 2022
NDC 52565-009-50, Lot #14217, August 2022
NDC 52565-009-50, Lot #13058, February 2022
NDC 52565-009-50, Lot #13768, May 2022
NDC 63739-997-64, Lot #16306, January 2024
Consumers and patients who have Lidocaine HCl Topical Solution 4% that is being recalled are asked to discontinue use and dispose of the product immediately.
Consumers can call 1-856-697-1441 from 8 a.m. to 5 p.m. weekdays or send an email to Medical@teligent.com for related questions. They should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail or by fax.
Complete and submit the report online at bit.ly/3vapWgx.
Regular mail or fax: Download form at bit.ly/2YT9Qwb or call 1800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.