Asthma Medication Recalled

Lupin Pharmaceuticals Inc is recalling 3216 bottles of zileuton extended-release tablets after long-term stability testing showed out-of-specification dissolution results, according to the June 22, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects zileuton extended-release tablets, 600 mg, in 120-count bottles (NDC 68180-169-16), from lots M100070 and M100239 (Exp. 6/22), M100312 (Exp. 9/22), and M100366 (Exp. 10/22).

The product was manufactured by Lupin Limited, Nagpur, India, for Lupin Pharmaceuticals, Inc, Baltimore, MD, and distributed to 10 wholesalers/distributors and 1 mail-order account that may have further distributed the product nationwide.

Lupin Pharmaceuticals voluntarily initiated the recall June 10, 2022. The FDA designated the recall Class II on June 15, 2022, communicating use of the drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Zileuton is a prescription anti-inflammatory medication used to prevent and control asthma attacks in patients 12 and older.