FDA recall D-0471-2024

Cipla USA, Inc. · Class II · drug

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.

Distribution

USA nationwide.

Key facts

Status
Terminated
Initiation date
2024-03-26
Report date
2024-05-01
Termination date
2025-07-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Warren, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0471-2024