Lidocaine HCl Topical Solution 4% recalled for higher than normal potency level

National News

(WTAJ)– A national recall has been issued for one lot of  Lidocaine HCl Topical Solution 4%, 50ml in a screw cap glass bottle to the user level due to higher than normal potency levels.

Teligent Pharma, Inc. issued the recall because the use of the product would result in a higher dose than what is expected.

“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,” the article by the FDA states.

Lot number 14218 that expires 9/2022 is packaged in a 50ml glass bottle with a screw cap with the identification NDC# 52565-009-50. This can be identified by the label “Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL). The image of the label is below.

The label of the Teligent Pharma’s recalled Lidocaine HCl Topical Solution 4%, 50ml FDA

The FDA encourages consumers with questions regarding this recall can contact Teligent Pharma, Inc. by phone at 1-856-697-1441 press * to reach the medical information call center Monday through Friday, 8 a.m. – 5 p.m. or send an e-mail to Medical@teligent.com. Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

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