Teligent Pharma is voluntarily recalling two lots of its lidocaine topical solution after the company found it to be super potent based on testing results obtained at the 9-month and 18-month stability timepoints — adding to a long list of issues faced by the NJ-based generics maker.
The recall is certainly not an isolated issue for Teligent. The drugmaker, who specializes in topical and injectable drugs, recalled one lot of the same product —Lidocaine HCl Topical Solution 4%, 50ml in a screw cap glass bottle to the user level — in September and another five lots in October.
The recalls are part of much larger problems for Teligent, however. The company's CEO and legal chief resigned without explanation in October, and shortly thereafter Teligent filed for bankruptcy protection, citing financial struggles stemming from repeated run-ins with the FDA over manufacturing issues at the company’s plant in Buena, N.J.
The company expects to consummate a sale of the entire business or its core assets by early 2022.
