March 2024 FDA Recall Ipratropium Bromide And Albuterol Sulfate by Cipla Usa, Inc.
D-0471-2024 - Short fill

This Class II drug recall was voluntarily initiated by Cipla Usa, Inc. on March 26, 2024 for the product Ipratropium Bromide And Albuterol Sulfate. The FDA reported the reason for recall as short fill. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0471-2024

Reason for Recall
Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Initiated
03-26-2024
Reported
05-01-2024
Quantity
59244/3ml FFS packs

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94289
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Cipla USA, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-09-2025
Product Description About Product Description
Full technical description of the product.
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

69097-173-64 Ipratropium Bromide And Albuterol Sulfate
69097-173-53 Ipratropium Bromide And Albuterol Sulfate