FDA MedWatch - Lidocaine HCl Topical Solution USP, 4% by Teligent Pharma:

U.S. Food and Drug Administration sent this bulletin at 12/08/2021 08:21 AM EST

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: Lidocaine HCl Topical Solution USP, 4% by Teligent Pharma: Recall - Due to Super Potency

AUDIENCE: Patient, Health Professional, Pharmacy

ISSUE: Teligent Pharma is recalling two lots of Lidocaine HCl Topical Solution USP, 4% - 50 mL because the firms testing has found it 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.

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 and the elderly who are more likely to use this product 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.

To date, Teligent Pharma has not received any reports of adverse events related to this recall.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: The product being recalled is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract.

RECOMMENDATIONS:

Consumers, distributors, and retailers that have product which is being recalled should stop using or distributing and return to place of purchase.
Consumers and patients that have Lidocaine HCl Topical Solution 4% which is being recalled are asked to discontinue use and call the company to reach the medical information call center.
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.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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