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
Reported: June 25, 2014 Initiated: May 28, 2014 #D-1387-2014
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
Details
- Recalling Firm
- Novartis Pharmaceuticals Corp.
- Units Affected
- Lot F0067: 45,834 units; Lot F0079: 63,321 units
- Distribution
- Nationwide
- Location
- Suffern, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Novartis Pharmaceuticals Corp.. Units affected: Lot F0067: 45,834 units; Lot F0079: 63,321 units.
Why was this product recalled? ▼
Failed Stability Specification; out of specification result for particle size distribution during stability testing
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 25, 2014. Severity: Low. Recall number: D-1387-2014.
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