Drug Safety Alerts

Lidocaine EXP Voluntary Recall

12/7/2021

On December 7, 2021, Teligent Pharma, Inc. issued a consumer-level recall of two lots of Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) NDC # 63739-0997-64. This recall was issued due to testing that found the product to be super potent based on an Out of Specification (OOS) result obtained at the 9-month (Lot 16345) and 18-month (Lot 15594) stability timepoint.

This may represent a potential health hazard or safety risk to patients using product affected by this recall.

This recall affects lot numbers 15594 exp. 05/2023 & 16345 exp. 01/2024.

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 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 can present very quickly. If local anesthetic systemic toxicity is not recognized and treated quickly, severe morbidity and even death can result. Adults, 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. According to Teligent Pharma, Inc., the company has not received any reports of adverse events related to this recall.

Consumers and patients who have the recalled lots of Lidocaine HCl Topical Solution 4% are asked to discontinue use and call 1-856-697-1441 press * to reach the medical information call center Monday through Friday, 8:00 am – 5:00 pm or send an e-mail to Medical@teligent.com for any product questions and to receive instructions on reimbursement and shipping information.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

CVS Caremark Response: This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information about the Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), please call Teligent toll-free at 1-856-697-1441, Monday through Friday, 8:00 am - 5:00 pm or send an e-mail to Medical@teligent.com. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit https://www.fda.gov.