FDAClass IIJanuary 3, 2024

Asmanex Twisthaler recall: CGMP Deviations

Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuation), 120 Metered Doses, Rx only, Manufactured for: Organon LLC, a…

Why was Asmanex Twisthaler recalled?

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

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?

Batch U027458

Product
Asmanex Twisthaler (mometasone furoate inhalation powder, 220 mcg per actuation), 120 Metered Doses, Rx only, Manufactured for: Organon LLC, a…
Recalling firm
CARDINAL HEALTHCARE
Quantity
3 units
Distribution
Nationwide USA
Recall date
January 3, 2024
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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