FDAClass IIIJune 25, 2014

Foradil Aerolizer recall

Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, Manufactured for: Merck, Sharpe & Dohne Corp., a…

Why was Foradil Aerolizer recalled?

Failed Stability Specification; out of specification result for particle size distribution during stability testing

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 F0067 exp. 06/14, F0079 exp. 04/15

Product
Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, Manufactured for: Merck, Sharpe & Dohne Corp., a…
Recalling firm
Novartis Pharmaceuticals Corp.
Quantity
Lot F0067: 45,834 units; Lot F0079: 63,321 units
Distribution
Nationwide
Recall date
June 25, 2014
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls