COPD Medication Recalled

Cipla USA Inc. is recalling two lots of ipratropium bromide and albuterol sulfate inhalation solution. According to the May 1, 2024, US Food and Drug Administration (FDA) Enforcement Report, customers have reported low fill in the respule and drops of liquid in the intact pouch.

The recall affects ipratropium bromide and albuterol sulfate inhalation solution, 0.5-mg and 3-mg/3-mL unit-dose vials, packaged in cartons containing 30 vials (six pouches of five 3-mL vials; NDC 69097-173-53), from lots IA30390 (Exp. 4/30/25) and IA30517 (Exp. 6/30/25). The product was manufactured by Cipla Ltd., Pithampur, India, for Cipla USA, Warren, New Jersey, and distributed throughout the United States.

Cipla USA voluntarily initiated the recall on March 26, 2024. The FDA designated it Class II on April 24, 2024. Per the classification, use of the medication could cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Ipratropium bromide and albuterol sulfate inhalation solution is a prescription drug indicated to treat bronchospasm associated with chronic obstructive pulmonary disease in patients requiring more than one bronchodilator.