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The National Agency for Food and Drug Administration and Control (NAFDAC) has received information from US FDA that Teligent Pharma, Inc. is voluntarily recalling two lots of Lidocaine HCl Topical Solution USP 4%, 50ml in a screw cap glass bottle. 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.
BACKGROUND:
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).
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 has not received any reports of adverse events that have been related to this recall.
PRODUCT DETAILS:
| Product | NDC | Lot Number | Expiration |
| Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50mL bottle |
63739-997-64 | 15594 | 05/2023 |
| 63739-997-64 | 16345 | 01/2024 |
PRODUCT LABEL PHOTO:
NAFDAC implores importers, distributors, retailers, and consumers to stop the importation, distribution, sale and use of the affected lots of Lidocaine HCI Topical Solution USP.
Members of the public in possession of the recalled lots are implored to discontinue sale or use, and hand over stock to the nearest NAFDAC office.
NAFDAC encourages healthcare professionals, consumers and patients to report adverse events related to the use of this product to the nearest NAFDAC office, NAFDAC PRASCOR (20543 TOLLS FREE from all networks) or via pharmacovigilance@nafdac.gov.ng or via the NAFDAC ADR e-Reporting platform available at www.nafdac.gov.ng or via med Safety App available for download on android and IOS stores.
NAFDAC……..Customer-focused, Agency-minded!!!
Signed Management
