A pharmaceutical company is recalling a batch of its topical pain reliever after the company tests found it to be “super potent.”
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Teligent Pharma, Inc. is recalling its topical 4% lidocaine hydrochloride solution, a 50 milliliter product that comes in a screw-top glass bottle, according to a press release from the Food and Drug Administration.
According to the FDA, companies that have tested the product have found it to be super potent based on an out-of-specification result. This potency could lead to “local anesthetic systemic toxicity,” according to the FDA.
“Systemic toxicity of local anesthetics can lead to central nervous system reactions, including excitement and / or depression, and more severe signs of cardiovascular toxicity, such as bradycardia, hypotension and even cardiovascular collapse can occur.” very quickly, âsays the notice. “If the systemic toxicity of the local anesthetic is not recognized and treated promptly, severe morbidity and even death can result.”
Teligent, which released the recall on Friday, said it had not received any reports of side effects.
Teligent is notifying its distributors via FedEx and arranging for the return of all recalled products, according to the FDA statement. Distributors, consumers and patients who have the recalled 4% lidocaine hydrochloride topical solution must return the product to their place of purchase, the FDA said.
Consumers with questions about the recall can contact Teligent Pharma, Inc. by phone at 1-856-697-1441 and press the asterisk button. . 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 email to[email protected]
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