FDA recall D-1387-2014

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

Reason for recall

Failed Stability Specification; out of specification result for particle size distribution during stability testing

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-05-28

Report date

2014-06-25

Termination date

2015-02-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Suffern, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1387-2014