FDAClass IIJune 2, 2021

Atrovent HFA 17mcg 12.9gm recall: CGMP Deviations

ATROVENT HFA 17MCG 12.9GM; NDC/UPC 597008717; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL

Why was Atrovent HFA 17mcg 12.9gm recalled?

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

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?

200155

Product
ATROVENT HFA 17MCG 12.9GM; NDC/UPC 597008717; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL
Recalling firm
Cardinal Health Inc.
Quantity
667 inhalers
Distribution
FL, GA, SC
Recall date
June 2, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls