Novartis Pharmaceuticals Corp. recalls Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, Manufactured for: M
Recalled June 25, 2014 · FDA recall D-1387-2014 · Novartis Pharmaceuticals
Hazard
Failed Stability Specification; out of specification result for particle size distribution during stability testing · FDA Class III
Units
Lot F0067: 45,834 units; Lot F0079: 63,321 units
Sold at
Nationwide
Description
Failed Stability Specification; out of specification result for particle size distribution during stability testing
Product
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
Manufacturer(s)
Novartis Pharmaceuticals Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →