Recalling firm
Cipla USA, Inc.
Product type
Drug
Status
Terminated
Report date
2024-05-01
Distribution
USA nationwide.
Firm state
NJ
Product quantity
59244/3ml FFS packs
Initiated by
Voluntary: Firm initiated
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
Code / lot info
Lot # IA30390, Exp 4/30/2025, IA30517, Exp 6/30/ 2025
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.