D-0471-2024 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 1, 2024
- Initiation Date
- March 26, 2024
- Termination Date
- July 9, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59244/3ml FFS packs
Product Description
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 Pattern
USA nationwide.
Code Information
Lot # IA30390, Exp 4/30/2025, IA30517, Exp 6/30/ 2025