Atorvastatin recall may affect hundreds of thousands of patients - and reflects FDA’s troubles inspecting medicines manufactured overseas
Yahoo••health
Key Points:
- A large recall of generic atorvastatin by Ascend Laboratories affects about 142,000 bottles due to tablets failing to dissolve properly, potentially reducing the drug's effectiveness in lowering LDL cholesterol and increasing cardiovascular risk.
- The FDA classified the recall as Class II, indicating the medication could cause temporary or medically reversible adverse health consequences, with defective batches produced from November 2024 through September 2025.
- Patients are advised not to stop taking atorvastatin without consulting healthcare providers, to check prescription labels for Ascend Laboratories as the manufacturer, and to seek alternatives if their medication is part of the recall.
- Many pharmaceutical manufacturing issues stem from overseas production, primarily in India and China, where FDA inspections are less frequent and often announced in advance,
