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FDAFDA · Food and drugs·Recall number D-1387-2014

Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, Manufactured for: Merck, Sharpe & Dohne Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, Manufactured by: Novartis Pharma AG Basle, Switzerland NDC 0085-1401-01

Published June 25, 2014 · Recall initiated: May 28, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Novartis Pharmaceuticals Corp.
Distributor
Nationwide
Lot
Lot F0067 exp. 06/14, F0079 exp. 04/15
Risk classification
Class III
Area (FDA)
drug
Country
United States

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