Teligent Pharma Recalls Lidocaine HCl Topical Solution USP 4%
Buena, New Jersey-based Teligent Pharma, Inc. is recalling two lots of Lidocaine HCl Topical Solution USP 4%, 50ml to the user level due to super potency, the U.S. Food and Drug Administration said.
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.
The affected Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) is packaged in a 50ml glass bottle with a screw cap with the identification NDC 63739-997-64. The lot codes are 15594 with expiration date of 05/2023, and 16345 with expiration date of 01/2024.
The product was distributed at the wholesale and retail distribution levels nationwide in the US.
The recall was initiated after the testing has found it to be super potent based on an Out of Specification or OOS result obtained at the 9-month (Lot 16345) and 18-month (Lot 15594) stability timepoint.
According to the regulator, use of the super potent product would result in a higher than intended lidocaine dose above that intended, which could lead to the development of local anesthetic systemic toxicity. This depends on the duration of the treatment and the specific patient.
If local anesthetic systemic toxicity is not recognized and treated quickly, severe morbidity and even death can result.
However, Teligent Pharma has not received any reports of adverse events related to the recall to date.
Consumers, distributors, and retailers that have the recalled product are urged to stop using or distributing and return to place of purchase.
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