Novartis Pharmaceuticals Corp. recalls Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsules (Blister strips of 6) per pac
Recalled June 24, 2015 · FDA recall D-1138-2015 · Novartis Pharmaceuticals
Hazard
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing. · FDA Class III
Units
55,442 packs
Sold at
NJ via 1 distributor
Description
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Product
Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889. Manufactured by: Novartis Pharma AG Basle,Via Serafino Balestra 31 Locarno, Switzerland.
Manufacturer(s)
Novartis Pharmaceuticals Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →