Novartis Pharmaceuticals Corp. recalls Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules (Blister strips of 6) per pac…
- Recall date
- May 22, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1137-2015
- FDA classification
- Class III
- Brand / firm
- Novartis Pharmaceuticals Corp.
- Sold / distributed
- NJ via 1 distributor
Why it was recalled
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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.
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