On December 7, 2021, the U.S. Food and Drug Administration (FDA) reported Teligent Pharma’s voluntary recall of two lots of lidocaine HCl topical solution 4% in a 50 ml screw cap glass bottle to the user level. The manufacturer’s testing found that the product is super potent based on an out-of-specification result at the 9-month (lot 16345) and 18-month (lot 15594) stability timepoint.
In the recall, Teligent Pharma advised that use of the super potent product can result in a higher-than-intended lidocaine dose, which could produce local anesthetic systemic toxicity depending on treatment duration and specific patient factors. Local anesthetic systemic toxicity can result in central nervous system reactions, including excitation and depression, and more serious signs of cardiovascular toxicity, such as bradycardia, hypotension, and cardiovascular collapse, can present very quickly. If local anesthetic systemic toxicity is not recognized and treated immediately, severe morbidity or death can result. Patients with lower body weights 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 the recall.
The recall affects the following lots of lidocaine HCl topical solution USP 4% (40 mg/ml), 50 ml bottles:
|
National Drug Code |
Lot Number |
Expiration |
|
63739-997-64 |
15594 |
05/2023 |
|
63739-997-64 |
16345 |
01/2024 |
The product is indicated for topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract. It was distributed at the wholesale and retail distribution levels nationwide.
FDA reported that Teligent Pharma is notifying its distributors and is arranging for the return of all recalled products. Patients who have the recalled lidocaine HCl topical solution 4% should discontinue use and dispose the product immediately.
Patients with questions regarding the recall can contact Teligent Pharma’s medical information call center at 856-697-1441, option *, Monday–Friday, from 8 am–5 pm, or at Medical@teligent.com.
Healthcare professionals and consumers should report any adverse reactions or quality problems they experienced using the product to MedWatch, FDA’s Safety Information and Adverse Event Reporting Program.