FDAClass IIOctober 5, 2022

Budesonide Inhalation Suspension 0.25mg/2mL recall: Sterility Concern

Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension…

Why was Budesonide Inhalation Suspension 0.25mg/2mL recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #s: GA20080, GA20081, GA20094, Exp. 01/2024

Product
Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules per pouch, Sterile Suspension…
Recalling firm
CIPLA
Quantity
641,160 ampules
Distribution
Nationwide in the USA and Puerto Rico
Recall date
October 5, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls