Drug recall D-0471-2024

Class II Terminated reported May 1, 2024

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.

Lots and codes

Lot # IA30390, Exp 4/30/2025, IA30517, Exp 6/30/ 2025

Recall details

Recalling firm
Cipla USA, Inc., Warren, NJ
Quantity
59244/3ml FFS packs
Distribution
USA nationwide.
Type
Voluntary: Firm initiated
Recall initiated
March 26, 2024
Terminated
July 9, 2025

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