COPD Drug Recalled

Cardinal Healthcare recalled two cartons of ipratropium bromide and albuterol sulfate solution because the drug was exposed to temperatures outside its labeled storage conditions, according to the January 3, 2024, US Food and Drug Administration (FDA) Enforcement Report. The recall affected ipratropium bromide and albuterol sulfate inhalation solution (0.5 mg/3 mg per 3 mL), 60 vials per carton/30 vials per foil pouch (NDC 69097-840-64), from batch 21C56. The solution was manufactured by the Ritedose Corporation, Columbia, South Carolina, and distributed by Cipla USA, Warren, New Jersey.

Cardinal Healthcare voluntarily initiated the recall January 26, 2022. On December 26, 2023, the FDA designated the recall Class II. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

The recall has been completed, the FDA report stated.

Ipratropium bromide and albuterol sulfate solution is a prescription medication indicated for the treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD) in patients requiring more than one bronchodilator.