Recall Alert: Teligent Says Lidocaine HCl Solution is Toxic Due to ‘Super Potency’

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Lidocaine HCl Solution Recall Overview:

• Who: Teligent Pharma has recalled one lot of its Lidocaine HCl Topical Solution 4%.
• Why: The topical solution has been found to be super potent, posing the risk of local anesthetic systemic toxicity.
• Where: The product is being recalled across the U.S. and Canada.

Teligent Pharma is voluntarily recalling one lot of its Lidocaine HCl Topical Solution 4% after testing found the solution was super potent and could lead to anesthetic systemic toxicity.

The product, which is used as a topical anesthesia for the mucous membranes in the oral and nasal cavities and portions of the digestive tract, has been sold across the U.S. and Canada, according to the Food and Drug Administration’s recall notice.

So far, Teligent has not received any reports of adverse events related to this recall, the FDA said.

Lidocaine HCl Topical Solution Recall Product Information

The solution comes in a 50ml glass bottle with a screw cap labeled with the identification NDC# 52565-009-50. The affected Lidocaine HCl Topical Solution 4% lot number and expiration date are:  Lot # 14218, Exp. 09/2022. All of the affected products carry the label: Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL).

Over the course of 18 months, testing found that use of the “super potent” product would result in a higher than intended lidocaine dose. The recall notice says 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 depression. More serious signs of cardiovascular toxicity, such as bradycardia, hypotension, and even cardiovascular collapse can present very quickly, the recall notice says.

According to the information in the recall, “if local anesthetic systemic toxicity is not recognized and treated quickly, severe morbidity and even death can result.”

Those who are more likely to use the products, such as the elderly and children of lower body weight, are more likely to experience local anesthetic systemic toxicity if a higher than intended lidocaine concentration is administered.

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, the FDA said.

Consumers with questions regarding this recall can contact Teligent by phone at 1-856-697-1441 press to reach the medical information call center Monday through Friday, 8 a.m. – 5 p.m. or send an email to Medical@teligent.com.

The Teligent recall isn’t the only recall that affects consumers who have trouble breathing. Philips has had to recall thousands of sleep and respiratory care devices that contain chemicals that put users at risk of carcinogenic effects, inflammation, irritation, and more, a new class action lawsuit alleges.

According to a class action lawsuit the company is facing, Philips Bi-Level Positive Airway Pressure (Bi-Level PAP), Continuous Positive Airway Pressure (CPAP), and mechanical ventilator devices all contain polyester-based polyurethane sound abatement foam which can degrade and release toxins into users’ airways.

Do you rely on any products to help you breathe easily? Tell us if you’ve ever had any issues

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