Recalls / Class III
Class IIID-1137-2015
Product
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.
- Affected lot / code info
- Lot #: F8011, Exp May 2015
Why it was recalled
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Recalling firm
- Firm
- Novartis Pharmaceuticals Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 25 Old Mill Rd, Suffern, New York 10901-4106
Distribution
- Quantity
- 19,658 packs
- Distribution pattern
- NJ via 1 distributor
Timeline
- Recall initiated
- 2015-05-22
- FDA classified
- 2015-06-15
- Posted by FDA
- 2015-06-24
- Terminated
- 2016-05-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1137-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.