Sterility concerns and out-of-spec testing results are two common sources of drug recalls. Now, the problems have hit two drugmakers at once. For one of the companies, it's far from the first time the FDA has raised manufacturing concerns.
Injectable and topical specialist Teligent Pharma and outsourcing facility Edge Pharma have issued separate recalls this month over superpotent test results and sterility concerns, respectively.
In Teligent's case, the company is recalling two lots of topical lidocaine solution after companies testing the drug received superpotent results at the nine-month and 18-month stability time points. The company faced similar problems in September, and it had a number of run-ins with the FDA prior to that.
As for Edge, the FDA-registered 503B outsourcing facility is recalling all lots of all drugs compounded and distributed from its facility in Colchester, Vermont.
Recall notices for both companies have been posted on the regulator's website.
In its release, Edge said it was yanking all its compounded products from the market because of “process issues” that could thwart the sterility of its products and hamper the safety and quality of its non-sterile drugs. The company didn't specify what those process issues were. Edge Pharma did not immediately respond to Fierce Pharma's request for comment.
Taking a drug that’s meant to be sterile but isn’t can cause site-specific infections, plus serious systemic infections that could be fatal, Edge Pharma said. As of Dec. 7, Edge said it hadn’t received any safety reports tied to the recall.
Edge is recalling a wide variety of products that come in containers, IV bags, syringes, drop containers, vials, bottles and jars. The recall covers sterile products such as lidocaine, dexamethasone, mitomycin and vancomycin, plus a slate of non-sterile products. In all, the recall affects more than 60 lots of Edge-made drugs.
As for Teligent’s superpotent lidocaine, use of the product could result in patients getting a higher dose than intended. Too much lidocaine could cause local anesthetic systemic toxicity, based on the duration of treatment and the specific patient, the company said. That toxicity can cause central nervous system reactions like excitation and depression, or more serious signs of cardiovascular toxicity, such as slower heart rate, low blood pressure and even cardiovascular collapse.
If local anesthetic systemic toxicity isn’t recognized and treated quickly, severe morbidity and death could follow, Teligent warned. Like Edge, Teligent has so far not received any safety reports linked to its recall.
The topical anesthetic was distributed nationwide across the U.S. The two lots were due to expire in May 2023 and January 2024.
Teligent didn't say where the lidocaine lots were manufactured, or by whom. The company didn't respond to Fierce Pharma's request for comment by press time.
The product pull comes after Teligent recalled one lot of lidocaine topical solution in September, again over superpotency concerns.
Teligent has faced a number of manufacturing issues in recent years. Two years back, the FDA reprimanded the specialty generics company for taking its skin med to market despite multiple failed 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.