Class III
Terminated
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.
This recall has been terminated (originally issued June 24, 2015).
- Company
- Novartis Pharmaceuticals Corp.
- Recall Initiated
- May 22, 2015
- Posted
- June 24, 2015
- Recall Number
- D-1137-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 19,658 packs
- Firm Location
- Suffern, NY, United States
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Lot #: F8011, Exp May 2015
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