A pharmaceutical company is recalling one lot of its topical pain reliever after company testing found it to be “super potent.”
Teligent Pharma, Inc. is recalling its Lidocaine HCl Topical Solution 4%, a 50-milliliter product issued in a screw cap glass bottle, according to a news release from the Food and Drug Administration.
According to the FDA, the firms testing the product found it to be super potent based on an Out of Specification result. That potency could lead to “local anesthetic systemic toxicity,” according to the FDA.
“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,” the notice states. “If local anesthetic systemic toxicity is not recognized and treated quickly, severe morbidity and even death can result.”
Teligent, which issued the recall on Friday, said it had not received any reports of adverse effects.
Teligent is notifying its distributors via FedEx and is arranging for the return of all recalled products, according to the FDA release. Distributors, consumers, and patients that have Lidocaine HCl Topical Solution 4% which is being recalled should return the product to their place of purchase, the FDA stated.
Consumers with questions about the recall can contact Teligent Pharma, Inc. by phone at 1-856-697-1441 and press the star key (*). Representatives from the medical information call center are available Monday through Friday, 8 a.m. to 5 p.m. EDT. Or, consumers can send an e-mail to Medical@teligent.com.
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