Reported Jun 24, 2015 · Terminated
Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsules (Blister strips of 6) per…
Novartis Pharmaceuticals Corp.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Novartis Pharmaceuticals Corp. · 25 Old Mill Rd · Suffern, NY · 10901-4106
Is this the product you have?
- 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 forMerck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889
- Manufactured byNovartis Pharma AG Basle,Via Serafino Balestra 31 Locarno, Switzerland
- Lot codes and dates
Lot#: F0082Exp May 2015
- Amount recalled
- 55,442 packs
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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