FDA Reports Worldwide Recall of Lidocaine HCl Topical Solution 4% Because of Super Potency

October 14, 2021

On October 13, 2021, the U.S. Food and Drug Administration (FDA) reported Teligent Pharma’s voluntary recall of five lots of lidocaine HCl topical solution 4% in a 50 ml screw cap glass bottle to the user level because the firm’s testing found it to be super potent based on an out-of-specification result obtained at the 18-month stability timepoint.

FDA Reports Worldwide Recall of Lidocaine HCl Topical Solution 4% Because of Super Potency

FDA reported that use of the super potent product would result in a higher-than-intended lidocaine dose, which could cause local anesthetic systemic toxicity depending on patient factors and treatment duration. Local anesthetic systemic toxicity can result in central nervous system reactions, including excitation or depression, and cardiovascular toxicity, such as bradycardia, hypotension, and cardiovascular collapse.

To date, Teligent Pharma, Inc., has not received any reports of adverse events related to the recall. The products were distributed at the wholesale and retail distribution levels in the United States and Canada.

The recall affects the following lots of lidocaine HCI topical solution USP 4% (40 mg/ml), 50 ml bottles:

National Drug Code

Lot Number

Expiration Date

52565-009-50

13262

03/2022

52565-009-50

14217

08/2022

52565-009-50

13058

02/2022

52565-009-50

13768

05/2022

63739-997-64

16306

01/2024

Teligent Pharma is notifying its distributors and is arranging for return of the recalled products. Patients that have the recalled lidocaine HCl topical solution 4% are asked to discontinue use and dispose of 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. Patients should consult their healthcare provider if they have experienced any problems that may be related to taking or using the product.

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.


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