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
D-0471-2024
Product summary
- Firm
- Cipla USA, Inc.
- Event
- Event 94289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 59244/3ml FFS packs
- Official record key
drug-enforcement:D-0471-2024
Official wording
Reason: Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Code information: Lot # IA30390, Exp 4/30/2025, IA30517, Exp 6/30/ 2025
Distribution pattern: USA nationwide.
Derived failure modes
-
Unknown
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.