Drug 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
D-1387-2014
Product summary
- Event
- Event 68282
- Status
- Terminated
- Classification
- Class III
- Quantity
- Lot F0067: 45,834 units; Lot F0079: 63,321 units
- Official record key
drug-enforcement:D-1387-2014
Official wording
Reason: Failed Stability Specification; out of specification result for particle size distribution during stability testing
Code information: Lot F0067 exp. 06/14, F0079 exp. 04/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification