Home / Recalls / Novartis Pharmaceuticals Corp. / D-1387-2014

D-1387-2014 Class III Terminated

Recalled by Novartis Pharmaceuticals Corp. — Suffern, NY

Recall Details

Product Type
Drugs
Report Date
June 25, 2014
Initiation Date
May 28, 2014
Termination Date
February 12, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Lot F0067: 45,834 units; Lot F0079: 63,321 units

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide

Code Information

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

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