Recall: D-0471-2024

Class II - Potentially Harmful

Class IIClassification

2024-03-26Initiated

TerminatedStatus

Cipla USA, Inc.Firm

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

Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.

Distribution

USA nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.