FDA-Drug2015-06-24Class III
Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 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.
Novartis Pharmaceuticals Corp.
Hazard
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Sold states
NJ via 1 distributor
Affected count
19,658 packs
Manufactured in
25 Old Mill Rd, Suffern, NY, United States
Products
Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1137-2015Don't want to check this manually?
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