Asthma Med Recalled

Teva Pharmaceuticals USA Inc is recalling 3772 cartons of montelukast sodium oral granules for failing to meet impurity specifications, according to the April 12, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects montelukast sodium oral granules, 4 mg, in cartons containing 30 packets (carton NDC 0093-7487-56, packet NDC 0093-7487-19), from lot 3007556A (Exp. 5/23). The drug was distributed by Teva Pharmaceuticals USA Inc, Parsippany, NJ, throughout the United States.

Teva Pharmaceuticals voluntarily initiated the recall on March 27, 2023. On April 6, 2023, the FDA designated the recall Class III, suggesting use of the recalled drug is not likely to cause harm.

Montelukast is a prescription respiratory tract agent used to control and prevent symptoms in patients with asthma and to relieve symptoms in patients with allergic rhinitis.