Product: Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-173-53
Reason for recall: Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Recall initiated: 20240326
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated