Class II

Drug Recall: 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: Ci

Cipla USA, Inc. · March 26, 2024

Reason for Recall

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

Product Description

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

Distribution

USA nationwide.

States Affected

NATIONWIDE

Quantity Affected

59244/3ml FFS packs

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0471-2024

Status: terminated

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.