Texas AG sues Pfizer over quality control lapses in kids ADHD drug

Pfizer said in a statement that it had examined the allegations in the complaint on "multiple occasions" and "did not find any impact on the safety of the product." It said it believed the case had no merit and would move to dismiss it.

A spokesperson for Tris said in an email: "We categorically deny and intend to rigorously defend these allegations in the court of law."

Tris manufactured Quillivant for Pfizer until 2018, when it acquired the product from Pfizer.

The lawsuit stems from a whistleblower complaint by Tarik Ahmed, who worked as Tris' head of technology from 2013 to 2017.

Quillivant was developed by Nextwave Pharmaceuticals, a company acquired by Pfizer in 2012.

Like other drugs for attention deficit/hyperactivity disorder, it has been plagued by shortages, and never achieved a large national market share. Tris acquired the product in 2018.

The U.S. Food and Drug Administration in 2017 warned Tris of manufacturing lapses.

In its 2022 annual report, Pfizer said it had received a subpoena from federal prosecutors in the Manhattan-based Southern District of New York related to its relationship with Tris and the production of Quillivant in 2018, but had not heard anything further after responding.