D-1387-2014 Class III Terminated
FDA drug recall D-1387-2014 was initiated by Novartis Pharmaceuticals Corp. on May 28, 2014 and is designated Class III. Reason for recall: Failed Stability Specification; out of specification result for particle size distribution during stability testing The recall status is terminated (terminated Feb 12, 2015). Affected quantity: Lot F0067: 45,834 units; Lot F0079: 63,321 units.
Recall details
- Product Type
- Drugs
- Report Date
- Jun 25, 2014
- Initiation Date
- May 28, 2014
- Termination Date
- Feb 12, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Lot F0067: 45,834 units; Lot F0079: 63,321 units
Product description
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
Reason for recall
Failed Stability Specification; out of specification result for particle size distribution during stability testing
Distribution pattern
Nationwide
Code information
Lot F0067 exp. 06/14, F0079 exp. 04/15
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1387-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026