Class III
Terminated
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
- Company
- Novartis Pharmaceuticals Corp.
- Recall Initiated
- May 28, 2014
- Posted
- June 25, 2014
- Recall Number
- D-1387-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- Lot F0067: 45,834 units; Lot F0079: 63,321 units
- Firm Location
- Suffern, NY, United States
Reason for Recall
Failed Stability Specification; out of specification result for particle size distribution during stability testing
Distribution
Nationwide
Lot / Code Info
Lot F0067 exp. 06/14, F0079 exp. 04/15
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