Recalls / Class III
Class IIID-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
- Affected lot / code info
- Lot F0067 exp. 06/14, F0079 exp. 04/15
Why it was recalled
Failed Stability Specification; out of specification result for particle size distribution during stability testing
Recalling firm
- Firm
- Novartis Pharmaceuticals Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 25 Old Mill Rd, N/A, Suffern, New York 10901-4106
Distribution
- Quantity
- Lot F0067: 45,834 units; Lot F0079: 63,321 units
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-05-28
- FDA classified
- 2014-06-17
- Posted by FDA
- 2014-06-25
- Terminated
- 2015-02-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1387-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.