D-0471-2024 Class II Terminated
FDA drug recall D-0471-2024 was initiated by Cipla USA, Inc. on Mar 26, 2024 and is designated Class II. Reason for recall: Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch. The recall status is terminated (terminated Jul 9, 2025). Affected quantity: 59244/3ml FFS packs.
Recall Details
- Product Type
- Drugs
- Report Date
- May 1, 2024
- Initiation Date
- Mar 26, 2024
- Termination Date
- Jul 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0471-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026