United States
FOR IMMEDIATE RELEASE –07 December 2021 – Buena, NJ, Teligent Pharma, Inc. is voluntarily recalling two lots of Lidocaine HCl Topical Solution USP 4%, 50ml in a screw cap glass bottle listed below to the user level. The product is being recalled 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.
Risk Statement: 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, Inc. has not received any reports of adverse events related to this recall.
Product: Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50mL bottle
NDC: 63739-997-64
Lot Number: 15594
Expiration: 05/2023
Product: Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50mL bottle
NDC: 63739-997-64
Lot Number: 16345
Expiration: 01/2024
The product 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 and is packaged in a 50ml glass bottle with a screw cap with the identification NDC 63739-997-64. The product can be identified by the following labeling: Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL). Product was distributed at the wholesale and retail distribution levels nationwide in the US.
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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company name: Teligent Pharma, Inc.
Brand name: Teligent Pharma, Inc.
Product recalled: Lidocaine HCl Topical Solution USP 4%, 50ml
Reason of the recall: Super potent
FDA Recall date: December 07, 2021
Check the full recall details on
www.fda.gov
Source: FDA
