Cipla USA, Inc.: Drug Recall

Recall #D-0471-2024 · 03/26/2024

Class II: Risk

Recall Details

Recall Number: D-0471-2024
Classification: Class II
Product Type: Drug
Recalling Firm: Cipla USA, Inc.
Status: Terminated
Date Initiated: 03/26/2024
Location: Warren, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 59244/3ml FFS packs

Reason for Recall

Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.

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

Distribution Pattern

USA nationwide.

Other Recalls by Cipla USA, Inc.

Class II: Risk 01/02/2026

Presence of Particulate Matter.
Class III: Low Risk 12/22/2025

Failed PH Specifications
Class II: Risk 11/14/2025

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II: Risk 11/14/2025

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II: Risk 11/14/2025

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

View all recalls by Cipla USA, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.