While still trying to address an FDA warning letter issued nearly two years ago, New Jersey pharma Teligent says it’s yanking a lot of its topical pain numbing treatment after testing found the med to be too potent.
Teligent is voluntarily recalling a lot of its topical lidocaine HCL solution, used to numb pain in the mouth, nose and throat, according to an FDA notice issued on Friday. The med, which comes in a 50-milliliter screw cap glass bottle, was found to be too potent during stability testing at 18 months.
The super potent lidocaine could cause a higher-than-intended dose for patients and local anesthetic systemic toxicity depending on how long a patient has used the treatment.
That could lead to cardiovascular problems, such as a slowed heart rate, low blood pressure and even cardiovascular collapse, Teligent warns. If not treated immediately, it could result in severe morbidity and death, the company says.
This isn’t the first manufacturing-related snafu Teligent has faced in recent years. The recall notice comes nearly two years after federal regulators reprimanded the specialty generic pharmaceutical company for taking its skin med to market despite multiple failed Out of Stability tests.
Teligent’s Buena, New Jersey, manufacturing site didn’t thoroughly investigate the test results for its clobetasol propionate cream, a corticosteroid used to treat skin conditions like eczema, the FDA said in a November 2019 warning letter. Despite failing stability tests at 9 months and 18 months, the company didn’t take any market action. It wasn't immediately made clear if the topical lidocaine was made at the same manufacturing facility.
At the time of the warning letter, the FDA warned Teligent that there were OOS issues with some of its other drugs and its Buena plant wasn’t testing drugs within the time frame laid out in its own procedures. The agency told Teligent to tap an independent review of all of its invalidated test results for products on the U.S. market.
But that wasn’t the end of Teligent’s troubles. Last summer, the FDA said the company failed to adequately address or provide adequate documentation to several of the concerns raised in its warning letter, company executives told analysts last year.
Teligent execs maintain that remedying the issues remains a "focal point," they told analysts last month on a conference call. The company expects another reinspection as the FDA works through its pandemic backlog.