Novartis Recalls Foradil Aerolizer Due to Stability Testing Failures
Novartis is recalling Foradil Aerolizer inhalation powder capsules because they failed stability specifications for particle size distribution.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text explicitly identifies the recall as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Novartis Pharmaceuticals Corp. is recalling Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 capsules, Rx only. The recall involves Lot F0067 (exp. 06/14) and Lot F0079 (exp. 04/15), which were distributed nationwide.
The recall was initiated because the product failed stability specifications, specifically showing out-of-specification results for particle size distribution during stability testing. The agency has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers with this medication should contact their healthcare provider or pharmacist for guidance on how to proceed. The product is manufactured for Merck, Sharpe & Dohne Corp. and manufactured by Novartis Pharma AG.
The recalled product
- 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…
- Manufacturer
- Novartis Pharmaceuticals Corp.
- Category
- Drug — Inhalation Powder
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot F0067 exp. 06/14
- F0079 exp. 04/15
Distribution
Distributed nationwide across the United States.
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