The Texas Attorney General has sued Pfizer over quality-control lapses at a plant that manufactures a popular ADHD drug for children. The lawsuit alleges that Pfizer failed to properly clean the plant, which led to the contamination of the drug with metal particles. The lawsuit also alleges that Pfizer failed to disclose the contamination to the Food and Drug Administration (FDA).
Background
The drug in question, Quillivant XR, is a long-acting stimulant medication used to treat attention deficit hyperactivity disorder (ADHD) in children aged 6 and older. The drug is manufactured at a Pfizer plant in St. Louis, Missouri.
Allegations of Quality-Control Lapses
The Texas Attorney General’s lawsuit alleges that Pfizer failed to properly clean the St. Louis plant, which led to the contamination of Quillivant XR with metal particles. The lawsuit also alleges that Pfizer failed to disclose the contamination to the FDA.
Impact of the Contamination
The metal particles found in Quillivant XR could potentially cause serious health problems in children, including:
- Allergic reactions
- Respiratory problems
- Gastrointestinal problems
- Neurological problems
Pfizer’s Response
Pfizer has denied the allegations in the lawsuit. The company has said that Quillivant XR is a safe and effective medication and that the company is committed to ensuring the quality of its products.
Implications of the Lawsuit
If the allegations in the lawsuit are proven, Pfizer could face significant legal and financial penalties. The lawsuit could also damage the company’s reputation and lead to a decline in sales of Quillivant XR.