FDA recall D-1138-2015

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.

Reason for recall

Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.

Distribution

NJ via 1 distributor

Key facts

Status

Terminated

Initiation date

2015-05-22

Report date

2015-06-24

Termination date

2016-05-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Suffern, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1138-2015