Class II
Terminated
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
- Company
- Cipla Usa, Inc.
- Recall Initiated
- March 26, 2024
- Posted
- May 1, 2024
- Recall Number
- D-0471-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 59244/3ml FFS packs
- Firm Location
- Warren, NJ, United States
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.
Lot / Code Info
Lot # IA30390, Exp 4/30/2025, IA30517, Exp 6/30/ 2025
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