Ipratropium Bromide And Albuterol Sulfate Solution
FDA Recall NDC 69097-173
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Ipratropium Bromide And Albuterol Sulfate (NDC 69097-173). A significant event, classified as Class II, was initiated on Mar 26, 2024 by Cipla Usa Inc.. The reported reason for this action was: "Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Mar 26, 2024
May 01, 2024
59244/3ml FFS packs
Recall Profile & Regulatory Data
Event ID
94289
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cipla USA, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Jul 09, 2025
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
Batch or Lot Expiration Information
Lot# IA30390, Exp 4/30/2025, IA30517, Exp 6/30/ 2025
Affected Packages Involved in this Recall
69097-173-64Product
69097-173-53Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
