FDA-Drug2024-05-01Class II
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
Cipla USA, Inc.
Hazard
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Sold states
USA nationwide.
Affected count
59244/3ml FFS packs
Manufactured in
10 Independence Blvd, N/A, Warren, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0471-2024Don't want to check this manually?
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